RecruitingNCT05245695
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Sponsor
Aspira Women's Health
Enrollment
1,200 participants
Start Date
Jul 12, 2022
Study Type
OBSERVATIONAL
Conditions
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 diagnosis" for endometriosis and to show validity as a diagnostic test
Eligibility
Sex: FEMALEMin Age: 14 YearsMax Age: 50 Years
Inclusion Criteria3
- 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 Criteria8
- 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
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Interventions
OTHERObservational study, no intervention
Observational study, no intervention
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05245695
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