Tag Archives: clinical trial

Rejoni Clinical Trial

This entry was posted in Ask An Expert and tagged clinical trial, Rejoni on July 2, 2024 by Dr. Kelly Roy, MD.

Intrauterine adhesions, also known as IUAs or Asherman’s Syndrome, are one of the most undiagnosed conditions among women in the United States. The adhesions are caused by damage to the lining of the uterus. The condition can lead to fertility issues and medical problems.

Fortunately, there is a new clinical trial on fibroids that is demonstrating the effectiveness of an innovative way to prevent the formation of these dangerous adhesions. The Rejoni clinical trial is led by physicians and features a gel-like material (Juveena™ Hydrogel) that may be effective at preventing the formation of intrauterine adhesions after surgery.

At Arizona Gynecology Consultants, we are committed to providing comprehensive healthcare for women using clinically proven techniques. Some of our clients may benefit from participating in this clinical trial on intrauterine adhesion.

What Are Intrauterine Adhesions?

The interior of the uterus is lined with a type of tissue called endometrium. During pregnancy, the embryo implants in this layer, but if no pregnancy occurs, the top layer of the endometrium is shed during menstruation. Any damage that occurs to the lining of the uterus can lead to the formation of scar tissue between the inner walls of the uterus.

Thin bands of scar tissue may form if the scarring is mild. Thick bands may form when the scarring is more severe. In either case, partial or total occlusion (blockage) of the inside of the uterus can occur.

The resulting conditions, commonly referred to as Asherman’s Syndrome, can develop after a uterine procedure like a dilation and curettage or hysteroscopy. Asherman’s Syndrome can cause serious fertility issues that require gynecology services in Arizona.

Primary adhesions can appear after pregnancy loss or surgery to remove fibroids. Secondary adhesions can happen after surgery to remove them, resulting in the adhesions returning. The adhesions may or may not cause noticeable symptoms.

How Does the Clinical Study Work?

Rejoni, Inc., a company based in Bedford, MA, is heading the study that tests whether a new hydrogel can prevent the formation of intrauterine adhesions. Any patient who is planning to undergo uterine surgery (either to disrupt existing adhesions through a procedure known as adhesiolysis or to remove fibroids) may be a candidate for the study.

Eligible participants will be randomly assigned to one of two groups: the treatment group, which will receive the hydrogel immediately after uterine surgery, or the control group, which will not receive the hydrogel. Two participants will be assigned to the treatment group for every participant in the control group. If you’re interested in this research trial, please schedule an appointment with Arizona Gynecology Consultants to determine if you qualify as a candidate.

Am I a Candidate For This Clinical Study?

If you have a history of intrauterine adhesions, you may be a great candidate for the Rejoni clinical study. Candidates may be able to prevent the recurrence of intrauterine adhesions by participating in the study. Women who have a history of being diagnosed with these types of adhesions may be good candidates for the clinical study.

If you are at least 18 years old and have received a diagnosis indicating that you require fibroid removal or adhesiolysis, you may qualify to participate in the Rejoni clinical trial or any similar clinical trial. There are no expenses associated with participating in this research. By joining this study, you can contribute to advancements in medical knowledge and potentially benefit from cutting-edge treatment options.

You will be provided with detailed information about the study procedures beforehand and questions you have will be thoroughly answered. Your participation could make a significant difference in the lives of others affected by similar conditions.

What Causes Intrauterine Adhesions?

Intrauterine adhesions can form after a surgical procedure involving the cavity of the uterus. Dilation and curettage (often used to diagnose and treat conditions) is an outpatient procedure that involves stretching the opening to the uterus and selectively removing parts of the uterus. The surgical procedures can result in intrauterine adhesions.

Dilation and curettage are often performed to control uterine bleeding and to address pregnancy complications. Less common causes of intrauterine adhesions include endometritis, surgical removal of fibroids, endometrial ablation, and cesarean sections.

What Are the Symptoms of Intrauterine Adhesions?

Intrauterine adhesions may cause significant symptoms or no symptoms at all.

Common symptoms include:

Menstrual abnormalities
Light or infrequent periods
Inability to achieve pregnancy
Recurrent miscarriages

Birth complications
Abnormal implantation of the placenta
Pelvic pain
Painful menstrual periods

These could be the symptoms of Asherman’s Syndrome or another medical problem that requires treatment at our Arizona gynecology center. We offer consultations for any of our exams and use minimally invasive treatments when possible.

How Are Intrauterine Adhesions Diagnosed?

Asherman Syndrome is often diagnosed by hysterosalpingogram, hysteroscopy, or saline sonohysterogram. Hysteroscopy is a highly accurate method for diagnosing intrauterine adhesions. It uses a lighted telescopic instrument to allow the doctor to see inside the uterus. The procedure can be performed in the operating room or a medical office.

Imaging procedures that use a special dye can view the shape of the inside of the uterus. A saline sonohysterogram uses a saltwater solution to expand the uterus so a sonogram machine can see the uterine cavity. Imaging can discover spaces where the fluid does not freely flow. While these procedures may not require anesthesia, anti-inflammatory medications may be prescribed to decrease post-procedure cramping.

Who Is at Risk For Intrauterine Adhesions?

Several factors can increase the risk of developing intrauterine adhesions. Women who have undergone uterine surgery following miscarriage, abortion, or delivery are at risk due to the potential for scarring. Certain surgical procedures like myomectomy for fibroid removal or the presence of uterine fibroids can lead to scarring.

Postpartum infections, endometritis, or genital tuberculosis can also increase the risk. When an intrauterine device (IUD) is not inserted correctly or left in place for extended periods, the device can damage the uterine lining and increase the risk of adhesions. Genetics is another leading factor, as some women may be more predisposed to developing scar tissue in the uterus.

Women may be at higher risk of developing intrauterine adhesions if they:

Have experienced complications related to cesarean sections
Have experienced repeated miscarriages
Are older
Have a condition that causes prolonged uterine bleeding, such as pelvic inflammatory disease.

Understanding these risk factors is crucial for identifying women who may be at higher risk of intrauterine adhesions and providing appropriate preventive measures or treatment.

Common Treatments For Intrauterine Adhesions

Physicians often recommend surgical treatments to address intrauterine adhesions because the scarring can lead to medical complications and fertility issues. Once the adhesions have been identified and diagnosed, your physician may use a special operating hysteroscope to cut and remove the scar tissue.

This procedure is frequently performed under anesthesia. After the adhesions have been removed, a special device may be placed to separate the walls of the uterus and decrease the chances that the adhesions will return.

To further reduce the risk of adhesions returning, your physician may prescribe hormonal treatment, nonsteroidal anti-inflammatory drugs, or antibiotics. The treatments are highly effective, but some women experience post-surgery lesions. The ongoing clinical trial on intrauterine adhesion aims to prevent the return of these types of adhesions.

Are There Risks Associated With Treating Intrauterine Adhesions?

The clinical trial may be able to prevent the return of intrauterine adhesions in some women. Any surgical procedure to remove existing adhesions can lead to absent or infrequent periods.

Women should be mindful that pregnancies after treatment could potentially be complicated by:

Miscarriage
Preterm labor
Third-trimester bleeding
Abnormal attachment of the placenta

Your women’s healthcare provider will explain how surgical removal of adhesions can affect future pregnancies and births. Women with mild-to-moderate adhesions often experience a resumption of normal menstrual function. Severe adhesions can affect fertility in some women. The Rejoni clinical trial is an important study because the advanced gel placed after surgical removal of adhesions may prevent the return of intrauterine adhesions.

Rejoini Clinical Trial FAQs

If you believe you are a good candidate for this or another ongoing clinical trial, please let someone with Arizona Gynecology Consultants know. We can determine your candidacy and help you start the process of undergoing treatment.

What Is Adhesiolysis?

A surgical procedure known as adhesiolysis treats intrauterine adhesions caused by Asherman’s syndrome. Under general anesthesia, a doctor dilates the cervix. This allows a hysteroscope to be inserted into the uterus. The surgeon identifies and removes scar tissue using a special instrument. The doctor then controls any bleeding. Patients are monitored after the procedure and given pain management if needed.

Am I a Candidate For the Rejoini Clinical Trial?

If you are 18 and older and have a history of developing intrauterine adhesions or have undergone fibroid removal or adhesiolysis, you may be a good candidate. The treatment prevents the return of adhesions following surgery. If you do not have intrauterine adhesions or a history of developing this type of scarring, you may not be a candidate for this specific clinical trial.

What Happens to the Treatment Group?

For every person selected as part of the control group, two women will be selected for the treatment group. These women will be given Juveena™ Hydrogel following the removal of an intrauterine adhesion. The study assesses whether the application of the gel prevents the return of adhesions in the uterus.

What Are the Benefits of Participating?

By participating in the Rejoni clinical trial, you may be chosen for the treatment group. The treatment gel may reduce the chances that intrauterine adhesions return. Preventing the return of adhesions could reduce the risk of fertility issues and other problems related to Asherman’s Syndrome.

How Do I Sign Up?

Before you can sign up for this clinical trial, one of our physicians will determine if you are a good candidate. We will provide you with everything you need to participate if you are found to be a candidate. At Arizona Gynecology Consultants, we are following national clinical trials and will recommend new clinical trial opportunities as they arise.

Contact Arizona Gynecology Consultants to See If You Are a Clinical Trial Candidate

Women who participate in the Rejoni clinical trial may be able to prevent the return of intrauterine adhesions. If you have a history of intrauterine adhesions and are 18 or over, you may be a great candidate for this study.

Arizona Gynecology Consultants is continually following new and ongoing clinical studies related to women’s health. When a study offers a safe and effective potential treatment for a condition we treat, we may recommend that our patients participate in the study.

It is important to remember that studies may involve the use of a control group, meaning that participating does not guarantee that you will have access to the new treatment being tested. Participation does help grow medical science’s body of knowledge, and you may directly benefit from those advancements. To learn if you are a candidate for the Rejoni clinical trial, please contact our office today.

Sources:

Parashar, S., Pajai, S., & Tarang, T. (n.d.). Recent Advancement in the Management of Intrauterine Adhesions Using Stem Cell Therapy: A Review Article. Cureus, 15(8), e43553. https://doi.org/10.7759/cureus.43553
Smikle, C., Yarrarapu, S. N. S., & Khetarpal, S. (2022). Asherman Syndrome. PubMed; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK448088/#:~:text=Asherman%20syndrome%20(intrauterine%20adhesions%20or
Intrauterine adhesions: what are they? (n.d.). Www.reproductivefacts.org. https://www.reproductivefacts.org/news-and-publications/fact-sheets-and-infographics/intrauterine-adhesions-what-are-they/

Dr. Kelly Roy, MD

Founder and Medical Director of ARIZONA GYNECOLOGY CONSULTANTS

Dr. Kelly Roy is a specialist in surgical gynecology and advanced laparoscopy (and hysteroscopy). She is a long-time resident of Arizona and obtained her Bachelor of Science degree in Biomedical Engineering at Arizona State University before finishing her Doctorate of Medicine at the University of Arizona in 1997.

Dr. Roy completed her residency in Obstetrics and Gynecology at the then “Banner Good Samaritan Hospital” (now Banner University Medical Center), in Phoenix Arizona in 2001.

Well known for her teaching and surgical ability, she is on the faculty at the residency program at both Banner University Medical Center and Saint Joseph’s Hospital in central Phoenix and is a Clinical Assistant Professor of Medicine at the University of Arizona College of Medicine, Phoenix Campus. Dr. Roy has taught advanced surgical techniques to medical students, residents, fellows and colleagues for over 15 years.

Dr. Roy is also a consultant to the medical device industry and has participated in the design and clinical testing of many instruments and surgical devices available on the world-wide market today.

azgyn.com/

EndoCheck Clinical Trial

This entry was posted in Ask An Expert and tagged clinical trial, Endometriosis on June 19, 2024 by Dr. Thomas J. Waliser.

1 out of 10 women have endometriosis, a condition that can significantly impact a person’s quality of life. As with many conditions, the earlier the diagnosis, the better the treatment outcomes. Unfortunately, laparoscopy, an invasive procedure, is currently the only definitive way to diagnose endometriosis.

What Is Endometriosis?

If you are facing a diagnostic laparoscopy due to your endometriosis-related symptoms, you may be eligible to participate in the EndoCheck clinical trial.

Endometriosis is a chronic medical condition in which tissue similar to the lining of the uterus, called the endometrium, grows outside the uterus. Normally, the endometrium remains within the uterus and simply thickens throughout the month before being shed during menstruation. With endometriosis, this tissue grows in the pelvic cavity, on the surface of the uterus, and other organs, such as the ovaries, fallopian tubes, and tissues lining the pelvis.

While the endometrium is shed during menstruation and exits via the vaginal opening, the tissue outside of the uterus has no way to leave the body. Over time, this can cause inflammation, scarring, and painful adhesions.

Stages of Endometriosis

Endometriosis is classified into stages based on the severity, extent, and location of the disease.

The staging system used to classify endometriosis is the Revised American Society for Reproductive Medicine (rASRM), which categorizes endometriosis into four stages.

Stage 1 endometriosis is considered minimal, typically with minimal adhesions or scar tissue, and generally localized within the pelvic cavity.
Stage 2 endometriosis is mild, with numerous or slightly larger lesions, and involves both ovaries and other pelvic structures.
Stage 3 endometriosis is moderate, with multiple implants or lesions and deeper infiltrating lesions affecting the ovaries, fallopian tubes, or uterus. It may distort the anatomy and organ function.
Stage 4 endometriosis is severe and consists of extensive implants or lesions scattered throughout the pelvic cavity. It may extend to other parts of the body, such as the bowels or bladder.

Endometriosis at a more advanced stage does not always mean you will have more severe symptoms or pain. For example, some women with stage 4 endometriosis may have few or no symptoms, whereas others with stage 1 can experience severe symptoms.

Endometriosis Evaluation and Diagnosis

In order to diagnose endometriosis, a doctor will assess medical history, perform a pelvic exam, and run diagnostic tests.

During the review of your medical history, your doctor will ask about your symptoms, whether you have any risk factors associated with endometriosis, your periods and pelvic pain, and whether you are experiencing infertility.

During the pelvic exam, your doctor will check for tenderness or pain. Afterward, your doctor may order imaging tests to examine the tissues around your pelvic area visually. Your doctor may make a “clinical diagnosis,” but this is not currently definitive without an invasive laparoscopy procedure.

A laparoscopy involves a small incision made in the abdomen near the belly button. The surgeon will insert a laparoscope – a long, thin tube equipped with a light and camera – through the incision before inflating the abdominal cavity with carbon dioxide gas. This will allow the surgeon to identify and examine any endometrial implants and even take a biopsy to send for laboratory analysis.

While laparoscopies are far less invasive than open-cavity surgery, they still involve some risk and recovery time. Fortunately, research is ongoing to demonstrate the effectiveness of a new diagnostic tool, the EndoCheck clinical test.

What Is EndoCheck?

If you are scheduled to undergo diagnostic laparoscopy to be evaluated for endometriosis, you may be eligible to access a non-invasive blood test called EndoCheck. This diagnostic test for endometriosis can help your gynecological professional diagnose endometriosis and guide decisions related to your ongoing care. Help us as we work to validate this procedure, potentially eliminating the need for laparoscopy in the future.

To be eligible to participate, you must:

Be able to provide written and informed consent or obtain the consent of an authorized representative or guardian.
Be a female aged 14 to 50 years old.
Be scheduled to undergo laparotomy or laparoscopy for suspected endometriosis.

How the EndoScope Clinical Trial Works

If you choose to participate, the endometriosis clinical trial will last approximately three months and include two visits to the Arizona Gynecology Consultants office. Upon arrival, you will complete an informed consent form along with an Endometriosis Health Profile Questionnaire and case report forms. Afterward, a blood sample will be collected.

After your laparoscopy, and if you are confirmed to have endometriosis, you will complete the Endometriosis Health Profile Questionnaire again. We will compare the results of the blood study test to the pathology reports and surgical observations obtained during your surgery.

Why Participate?

The goal of EndoCheck is to evaluate a new investigational test that may be able to detect endometriosis without the invasive procedure. Participating in this study allows you to be a part of changing the endometriosis prognosis journey and improving women’s quality of life. It may also reveal additional information about the medical roots of endometriosis.

Endometriosis Causes

The exact cause of endometriosis is not clear, but researchers have identified some promising theories.

Retrograde Menstruation

One theory suggests that during menstruation, some of the menstrual blood containing endometrial cells flows backward through the fallopian tubes into the pelvic cavity instead of leaving the body. These cells then implant and grow on the pelvic organs, causing endometriosis.

Coelomic Metaplasia

The theory of coelomic metaplasia suggests that certain cells lining the pelvic cavity can transform into endometrial-like tissue in response to hormonal or inflammatory signals. These transformed cells then create endometriosis lesions.

Embryonic Cell Changes

Some researchers speculate that endometriosis may result from embryonic cells that retain the ability to develop into various types of tissue, including endometrial-like tissue. These cells may become misplaced during embryonic development and create endometriosis lesions later in life.

Surgical Scar Complication

Surgical procedures involving the reproductive organs or pelvic cavity can cause tissue trauma, inflammation, and scarring, which may create an environment prime for the development of endometriosis. Inflammatory processes associated with surgical healing can promote the adhesion and proliferation of endometrial cells outside of the uterus.

Immune System Condition

A potential problem with the immune system is that the body may not recognize and destroy endometriosis tissue since it is produced within the body. Endometriosis has also been associated with systemic lupus erythematosus (SLE) and Hashimoto’s thyroiditis.

Genetics

Endometriosis may affect some people more often due to a genetic trait passed down in their families. Women with a close relative who has endometriosis, such as a mother, sister, or daughter, are at an increased risk of developing the condition themselves compared to those with no family history.

Endometriosis Symptoms

The main symptom of endometriosis is pelvic pain, often linked with menstruation. This pain can be a dull ache, cramping, or even sharp stabbing sensations, depending on the person. It may even worsen over time.

Other common symptoms include:

Painful Periods

Painful periods, medically known as dysmenorrhea, are a common symptom of endometriosis. This pain can be debilitating and may interfere with daily activities and quality of life. Some people with endometriosis experience deep pelvic pain or pressure during menstruation from the presence of endometrial implants or lesions near the cervix, uterus, ovaries, or rectum. Endometriosis pain can also impact the lower back, thighs, or buttocks.

Dyspareunia

Dyspareunia occurs when endometrial or scar tissue in the pelvic region causes pain or discomfort during sexual intercourse. This can lead to difficulties with intimacy and potential strain on relationships.

Infertility

Endometriosis is the leading cause of infertility in women, affecting up to 30-50% of women who experience infertility. The disease can distort pelvic anatomy, interfere with ovulation, and damage eggs and sperm. Alterations in the endometrial lining may also affect embryo implantation and early pregnancy development, along with changes in hormone levels, inflammation, and immune system dysfunction.

Gastrointestinal Symptoms

Endometrial growths on pelvic organs and bowels can lead to bloating, constipation, diarrhea, abdominal cramping, and nausea and vomiting. Endometrial growths or adhesions near the rectum or sigmoid colon can cause discomfort or pain during bowel movements. These can all worsen during menstruation.

Fatigue

Chronic pain and discomfort, pain management, coping with symptoms, and disrupted sleep patterns can contribute to fatigue and exhaustion. This is an often overlooked symptom, but it can significantly impact a person’s quality of life.

Urinary Symptoms

Some women may experience endometrial growths that affect the urinary tract. Endometriosis can cause interstitial cystitis (IC), which is a chronic condition that causes bladder pain, urinary urgency, frequency, and discomfort. Women with endometriosis may also be at an increased risk of urinary tract infections because of urinary retention, inflammation, or obstruction caused by endometrial growths or adhesions.

Other Symptoms

Endometriosis can also cause back pain, leg pain, heavy menstrual bleeding, and irregular menstrual cycles. The extent and severity of these symptoms will vary among each individual, and some women do not have any symptoms. As mentioned, having a more advanced stage of endometriosis, such as stage 4, does not mean more severe symptoms or pain.

Many symptoms may not be typically associated with endometriosis, which can complicate diagnosis and treatment. People may think they have irritable bowel syndrome (IBS) or uterine fibroids, but diagnostics reveal endometriosis.

Treatment Options

While endometriosis currently has no cure, there are treatment options available to help manage pain, slow tissue and implant growth, and help with potential infertility.

The first line of treatment is medication, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, combined (estrogen-progestin) contraceptives, progestin, gonadotrophin-releasing hormone (GnRH) agonists, danazol, or aromatase inhibitors are the most commonly prescribed.

If medications are not working, surgery may be a choice. Surgeries may be used to remove scar tissue and endometrial implants or hysterectomy with or without bilateral scalping-oophorectomy. This involves the removal of the uterus while leaving or removing the ovaries and fallopian tubes.

What are the Risk Factors for Endometriosis?

It is possible to develop endometriosis later in life, but it usually manifests during a woman’s reproductive years.

Factors that raise the risk of endometriosis include:

Starting your period at an early age
Starting menopause at an older age
An abnormal uterus
Heavy periods that are longer than seven days
A menstrual cycle that is shorter than 27 days
Higher levels of estrogen in your body or greater exposure to estrogen than your body normally produces
Low body mass index
You have a genetic connection to family members with endometriosis.

Additionally, any health condition that prevents menstrual blood from leaving your body can increase your risk of endometriosis.

Help Reduce the Impact of Endometriosis

Endometriosis can significantly impact a woman’s life, including physical health, emotional well-being, relationships, work, and social activities, due to severe pain, fatigue, infertility, anxiety, and depression. Addressing endometriosis will help empower those experiencing it and improve women’s sexual and reproductive health, quality of life, and well-being. First, however, it’s crucial to make the process of diagnosing endometriosis as painless and stress-free as possible. We urge you to consider participating in the EndoCheck clinical trial and potentially help minimize the impact of endometriosis on others.

If you’re interested, please contact your surgeon at Arizona Gynecology Consultants for further information.

Resources:

Endometriosis. (2021, February). Www.acog.org. https://www.acog.org/womens-health/faqs/endometriosis
World Health Organization. (2023, March 24). Endometriosis. World Health Organization; World Health Organization. https://www.who.int/news-room/fact-sheets/detail/endometriosis
Matsuura, K., Ohtake, H., Katabuchi, H., & Okamura, H. (1999). Coelomic metaplasia theory of endometriosis: evidence from in vivo studies and an in vitro experimental model. Gynecologic and Obstetric Investigation, 47 Suppl 1, 18–20; discussion 20-2. https://doi.org/10.1159/000052855
John Hopkins Medicine. (2024). Endometriosis. John Hopkins Medicine. https://www.hopkinsmedicine.org/health/conditions-and-diseases/endometriosis
Endometriosis. (n.d.). Yale Medicine. https://www.yalemedicine.org/conditions/endometriosis
Mayo Clinic. (2023, October 12). Endometriosis – Symptoms and Causes. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/endometriosis/symptoms-causes/syc-20354656
Bafort, C., Beebeejaun, Y., Tomassetti, C., Bosteels, J., & Duffy, J. M. (2020). Laparoscopic surgery for endometriosis. Cochrane Database of Systematic Reviews, 10(10). https://doi.org/10.1002/14651858.cd011031.pub3
Endometriosis: Does It Cause Infertility? (n.d.). Www.reproductivefacts.org. https://www.reproductivefacts.org/news-and-publications/fact-sheets-and-infographics/endometriosis-does-it-cause-infertility/
American Society for Reproductive. (1997). Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertility and Sterility, 67(5), 817–821. https://doi.org/10.1016/s0015-0282(97)81391-x

Dr. Thomas J. Waliser

Dr. Waliser is a gynecology specialist, performs minimally invasive surgery, and has been practicing medicine for over 22 years, primarily in the Scottsdale and Tucson areas. He graduated from the University of North Dakota School of Medicine & Health Sciences and completed his residency at St. Francis Hospital. Dr. Waliser is fellowship trained in Advanced Laparoscopy/Hysteroscopy and is board certified.