Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)

Last updated: June 23, 2025
Sponsor: Aspira Women's Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Endometriosis

Treatment

Observational study, no intervention

Clinical Study ID

NCT05245695
12-2021
  • Ages 14-50
  • Female

Study 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

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 symptomologyconsistent with possible endometriosis

Exclusion

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 orhepatitis A, B, or C.

  • Participant has an active pelvic infection or other infections contraindicated forsurgery.

  • Participant has participated (±3 months of study enrollment) in a clinical trialwhere an investigational drug/ device/ procedure was or is planned to beadministered.

  • Participant has any general health or behavioral condition that, in the opinion ofthe investigator, should exclude the participant from participation.

  • Participant is under 14 years old or over 50 years old

Study Design

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Observational study, no intervention
Phase:
Study Start date:
July 12, 2022
Estimated Completion Date:
June 30, 2026

Study Description

The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain.

The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.

Connect with a study center

  • New Horizons Clinical Trials

    Chandler, Arizona 852224
    United States

    Active - Recruiting

  • Arizona Gynecology Consultants

    Mesa, Arizona 85203
    United States

    Site Not Available

  • Velvet Clinical Research

    Burbank, California 91506
    United States

    Active - Recruiting

  • Reproductive Associates of Delaware

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Reproductive Associates of Delaware (RAD)

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Midtown OBGYN North

    Columbus, Georgia 31909
    United States

    Active - Recruiting

  • Advanced Women's Care Center

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Axia

    Greenwood, Indiana 46143
    United States

    Site Not Available

  • Axia Women's Health

    Greenwood, Indiana 46143
    United States

    Active - Recruiting

  • Cindy Basinski, MD

    Newburg, Indiana 47630
    United States

    Active - Recruiting

  • Cindy Basinski, MD

    Newburgh, Indiana 47630
    United States

    Site Not Available

  • Johns Hopkins School of Medicine

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Axia Women's Health

    Moorestown, New Jersey 08057
    United States

    Site Not Available

  • Nezhat Surgery for Gynecology/Oncology

    Valley Stream, New York 11581
    United States

    Active - Recruiting

  • Axia Women's Health

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Seven Hills Clinical Research

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • May Grant

    Lancaster, Pennsylvania 17601
    United States

    Active - Recruiting

  • Womens Health Services of Central Virginia

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

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