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.
Age
14–50
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
