Status:
RECRUITING
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Lead Sponsor:
Aspira Women's Health
Conditions:
Endometriosis
Eligibility:
FEMALE
14-50 years
Brief 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 d...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05245695
Start Date
July 12 2022
End Date
June 30 2026
Last Update
June 25 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
New Horizons Clinical Trials
Chandler, Arizona, United States, 852224
2
Velvet Clinical Research
Burbank, California, United States, 91506
3
Reproductive Associates of Delaware (RAD)
Newark, Delaware, United States, 19713
4
Midtown OBGYN North
Columbus, Georgia, United States, 31909