Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Recruiting · NCT05245695 · Observational (researchers observe without assigning treatment) · Lead sponsor: Aspira Women's Health
View the official record on ClinicalTrials.gov →Interventions studied
Observational study, no intervention
What this trial is about
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
Who can take part
Age range
14 Years to 50 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
10 locations listed across 9 US states.
- New Horizons Clinical Trials - Chandler, Arizona, United States
- Velvet Clinical Research - Burbank, California, United States
- Reproductive Associates of Delaware (RAD) - Newark, Delaware, United States
- Midtown OBGYN North - Columbus, Georgia, United States
- Advanced Women's Care Center - Stockbridge, Georgia, United States
- Cindy Basinski, MD - Forest Hill, Indiana, United States
- Johns Hopkins School of Medicine - Baltimore, Maryland, United States
- Nezhat Surgery for Gynecology/Oncology - Valley Stream, New York, United States
- Seven Hills Clinical Research - Cincinnati, Ohio, United States
- Womens Health Services of Central Virginia - Lynchburg, Virginia, United States