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
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.
Study Type
OBSERVATIONAL
Enrollment
1,200
Observational study, no intervention
New Horizons Clinical Trials
Chandler, Arizona, United States
RECRUITINGVelvet Clinical Research
Burbank, California, United States
RECRUITINGSensitivity and Specificity
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
Time frame: 24 months
Performance
Examining the performance of the test in patients stratified by pain severity and other clinical factors.
Time frame: 24 months
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Reproductive Associates of Delaware (RAD)
Newark, Delaware, United States
RECRUITINGMidtown OBGYN North
Columbus, Georgia, United States
RECRUITINGCindy Basinski, MD
Forest Hill, Indiana, United States
RECRUITINGJohns Hopkins School of Medicine
Baltimore, Maryland, United States
RECRUITINGNezhat Surgery for Gynecology/Oncology
Valley Stream, New York, United States
RECRUITINGSeven Hills Clinical Research
Cincinnati, Ohio, United States
RECRUITINGMay Grant
Lancaster, Pennsylvania, United States
RECRUITINGWomens Health Services of Central Virginia
Lynchburg, Virginia, United States
RECRUITING