Recruiting

EndoCheck

Sponsor:

Aspira Women's Health

Code:

NCT05245695

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 14 - 50

Healthy Volunteers: Not accepted

Interventions

Observational study, no intervention

Study Details

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

Conditions

Endometriosis

Study ID

NCT05245695

Start date

Jul 12, 2022

Status verified date

Jun, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Observational study, no intervention

Observational study, no intervention

Primary outcome measure

  • Sensitivity and Specificity [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Marla Then, CRC

844-277-4721mthen@aspirawh.com

Silvana Franco

sfranco@aspirawh.com

Locations

New Horizons Clinical Trials

Recruiting

Chandler, Arizona, United States, 852224

Contacts

Saira Flores, MD

sflores@aoafamily.com

(480) 496-2236

Principal Investigator:

Monte Swarup

Velvet Clinical Research

Recruiting

Burbank, California, United States, 91506

Contacts

Monica Torres

3235270907mtorres@velvetclinicalresearch.com

Principal Investigator:

Jose Medrano, MD

Reproductive Associates of Delaware (RAD)

Recruiting

Newark, Delaware, United States, 19713

Contacts

Eileen Davies

edavies@radfertility.com

Principal Investigator:

Ronald Feinberg

Midtown OBGYN North

Recruiting

Columbus, Georgia, United States, 31909

Contacts

Rebecca Watkins

rebeccaw@midtownob.com

Principal Investigator:

Serena Tidwell

Advanced Women's Care Center

Recruiting

Stockbridge, Georgia, United States, 30281

Contacts

Kristina Louissaint

770-538-1723info@advancedwomenscarecenter.com

Principal Investigator:

Tamika Sea, MD

Cindy Basinski, MD

Recruiting

Forest Hill, Indiana, United States, 47630

Contacts

Alicia Sollman

812-853-3500alicia@drbasinski.com

Principal Investigator:

Cindy Basinski, MD

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Samya El Sayed, MD

selsaye4@jh.edu

Principal Investigator:

James Segar, Dr

Nezhat Surgery for Gynecology/Oncology

Recruiting

Valley Stream, New York, United States, 11581

Contacts

Sharon Cote, MD

sharon@farrnezhatmd.com

Principal Investigator:

Farr Nezhat, MD

Seven Hills Clinical Research

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Brigette Tillman

brigette.tillman@axiawh.com

Principal Investigator:

Gerard Reilly

Womens Health Services of Central Virginia

Recruiting

Lynchburg, Virginia, United States, 24502

Contacts

Whittney Calohan

434-485-7059wcalohan@whscv.com

Principal Investigator:

Wade Neiman

More Information

Sponsor

Aspira Women's Health

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Endometriosis
  • Biomarkers
  • Deep neural network

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Aspira Women's Health on 2026-06-04.