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Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers

NCT05698212 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-01-26

No results posted yet for this study

Summary

This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery. The tissue is sent to lab for cellular analysis with a proprietary AI (artificial intelligence) technology.

Conditions

  • Endometriosis
  • Diagnosis

Interventions

DIAGNOSTIC_TEST

MetriDx

Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record

Sponsors & Collaborators

  • Hera Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Sandra M Hurtado, MD · University of Texas Physicians Women's Center

  • Charles R Kirkham, MD · Corpus Christi Women's Clinic

  • Jacqueline A Robinson, MD · Valley OB-GYN Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2023-03-25
Completion
2023-04-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05698212 on ClinicalTrials.gov