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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Advanced Women's Care Center
  Stockbridge, Georgia, United States Recruiting
• Cindy Basinski, MD
  Forest Hill, Indiana, United States Recruiting

Study contacts

• Principal investigator: Todd Pappas, PhD — Aspira Women's Health
• Study coordinator: Marla Then, CRC
• Email: mthen@aspirawh.com
• Phone: 844-277-4721

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing different techniques to treat endometriosis

  This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.

  Recruiting TriHealth Inc. · Cincinnati, Ohio · NCT06414083

• Postoperative Pain Trajectories After Endometriosis Surgery

  This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07882498

• Imaging endometriosis with a special PET tracer in adult women

  This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07876648

• Fiber supplement for digestive symptoms in endometriosis

  A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.

  Recruiting LOAM Science · San Francisco, California · NCT07875062

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

  The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.

  Recruiting The Second People's Hospital of Huai'an · Huai'an, Jiangsu · NCT07860203

• Atypical Endometriosis: Histology, Immunophenotype and Molecular Features

  Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.

  Recruiting Casa di Cura Dott. Pederzoli · Peschiera del Garda, Verona · NCT07816133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.