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

February 15, 2024 updated by: Aspira Women's Health

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 852224
        • Recruiting
        • New Horizons Clinical Trials
        • Contact:
          • Phone Number: (480) 496-2236
        • Principal Investigator:
          • Monte Swarup
        • Contact:
      • Mesa, Arizona, United States, 85203
        • Recruiting
        • Arizona Gynecology Consultants
        • Contact:
        • Principal Investigator:
          • Kelly Roy, MD
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Reproductive Associates of Delaware (RAD)
        • Principal Investigator:
          • Ronald Feinberg
        • Contact:
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Recruiting
        • Midtown OBGYN North
        • Contact:
        • Principal Investigator:
          • Serena Tidwell
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Advanced Women's Care Center
        • Contact:
        • Principal Investigator:
          • Tamika Sea, MD
    • New York
      • Valley Stream, New York, United States, 11581
        • Recruiting
        • Nezhat Surgery for Gynecology/Oncology
        • Contact:
        • Principal Investigator:
          • Farr Nezhat, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45242
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Recruiting
        • May Grant
        • Principal Investigator:
          • Kent Meldrum
        • Contact:
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Recruiting
        • Womens Health Services of Central Virginia
        • Contact:
          • Whittney Critchley
          • Phone Number: 434-485-7059
        • Principal Investigator:
          • Wade Neiman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women scheduled for a gynecologic surgery

Description

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 secondary to chronic pain associated with suspected endometriosis.

Exclusion Criteria:

  • Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: 24 months
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance
Time Frame: 24 months
Examining the performance of the test in patients stratified by pain severity and other clinical factors.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aspira Women's Health

Investigators

  • Principal Investigator: Todd Pappas, PhD, Aspira Women's Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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