About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Women scheduled for a gynecologic surgery
Trial design
Case-control
Prospective
Treatments tested in this trial
Observational study, no intervention
Other interventionObservational study, no intervention
Treatment groups
Trial outcomes
Primary outcomes
Sensitivity 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
Secondary outcomes
Performance
Examining the performance of the test in patients stratified by pain severity and other clinical factors.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.