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NCT05245695
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Conditions: Endometriosis
Sex: Female
Ages: 14 Years – 50 Years
Healthy volunteers: No
Enrollment: 1200
Sponsor: Aspira Women's Health
Location: New Horizons Clinical Trials Chandler Arizona
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 Criteria
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
Source: ClinicalTrials.gov (NCT05245695). StuddyBuddy aggregates publicly available trial information.