Using a deep neural network to help diagnose endometriosis in women with chronic pelvic pain

Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)

This study is testing a new tool called EndoCheck to see if it can help doctors diagnose endometriosis in women who have chronic pelvic pain, comparing its results to traditional surgery.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 14 Years to 50 Years
• Sex: Female
• Sponsor: Aspira Women's Health (Industry-sponsored)
• Locations: 10 sites (Chandler, Arizona and 9 other locations)
• Trial ID: NCT05245695 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the clinical validity of the EndoCheck algorithm, which utilizes protein biomarker detection to assist in diagnosing endometriosis. The study will compare the performance of EndoCheck against laparoscopic surgical assessment in women experiencing chronic pelvic pain. The primary goal is to achieve a sensitivity of at least 94% and specificity of 79% for the diagnostic test, with secondary endpoints focusing on performance across different pain severity levels and clinical factors.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 14 to 50 who are scheduled for laparotomy or laparoscopy due to symptoms suggestive of endometriosis.

Not a fit: Patients who are pre-menarchal, pregnant, or have active malignancies or infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accurate and less invasive method for diagnosing endometriosis in women suffering from chronic pelvic pain.

How similar studies have performed: While the use of deep neural networks in medical diagnostics is a growing field, this specific application for endometriosis detection is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Participant is willing and able to provide written informed consent.
* Participant is a female aged 14 to 50 years old at time of consent.
* Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis

Exclusion Criteria:

* Participant is a female in a pre-menarchal state.
* Participant is pregnant.
* Participant has an active malignancy.
* Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
* Participant has an active pelvic infection or other infections contraindicated for surgery.
* Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered.
* Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
* Participant is under 14 years old or over 50 years old

Where this trial is running

Chandler, Arizona and 9 other locations

• New Horizons Clinical Trials — Chandler, Arizona, United States (Recruiting)
• Velvet Clinical Research — Burbank, California, United States (Recruiting)
• Reproductive Associates of Delaware (RAD) — Newark, Delaware, United States (Recruiting)
• Midtown OBGYN North — Columbus, Georgia, United States (Recruiting)
• Cindy Basinski, MD — Forest Hill, Indiana, United States (Recruiting)
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
• Nezhat Surgery for Gynecology/Oncology — Valley Stream, New York, United States (Recruiting)
• Seven Hills Clinical Research — Cincinnati, Ohio, United States (Recruiting)
• May Grant — Lancaster, Pennsylvania, United States (Recruiting)
• Womens Health Services of Central Virginia — Lynchburg, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Todd Pappas, PhD — Aspira Women's Health
• Study coordinator: Marla Then, CRC

Conditions Endometriosis; Biomarkers; Deep neural network