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)

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

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

May Grant

Lancaster, Pennsylvania, United States

Womens Health Services of Central Virginia

Lynchburg, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05245695


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