Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
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
Interventions
Observational study, no intervention
Conditions
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