Back to Trials
NCT05245695Recruiting

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

Aspira Women's Health

Start Date

7/12/2022

Completion Date

6/30/2026

Summary

The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test

Detailed Description

The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain. The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.

Eligibility Criteria

Age Range: 14 years to 50 years

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

Interventions

OTHER

Observational study, no intervention

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Endometriosis

Locations

New Horizons Clinical Trials

Chandler, Arizona 852224

United States

Velvet Clinical Research

Burbank, California 91506

United States

Reproductive Associates of Delaware (RAD)

Newark, Delaware 19713

United States

Midtown OBGYN North

Columbus, Georgia 31909

United States

Advanced Women's Care Center

Stockbridge, Georgia 30281

United States

Cindy Basinski, MD

Forest Hill, Indiana 47630

United States

Johns Hopkins School of Medicine

Baltimore, Maryland 21205

United States

Nezhat Surgery for Gynecology/Oncology

Valley Stream, New York 11581

United States

Seven Hills Clinical Research

Cincinnati, Ohio 45242

United States

Womens Health Services of Central Virginia

Lynchburg, Virginia 24502

United States