NCT05245695 Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
| NCT ID | NCT05245695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aspira Women's Health |
| Condition | Endometriosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2022-07-12 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2022-07-12 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Todd Pappas, PhD
PRINCIPAL INVESTIGATOR
Aspira Women's Health
Frequently Asked Questions
Who can join the NCT05245695 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 50 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05245695 currently recruiting?
Yes, NCT05245695 is actively recruiting participants. Contact the research team at mthen@aspirawh.com for enrollment information.
Where is the NCT05245695 trial being conducted?
This trial is being conducted at Chandler, United States, Burbank, United States, Newark, United States, Columbus, United States and 6 additional locations.
Who is sponsoring the NCT05245695 clinical trial?
NCT05245695 is sponsored by Aspira Women's Health. The principal investigator is Todd Pappas, PhD at Aspira Women's Health. The trial plans to enroll 1,200 participants.