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

Part of paid clinical trials in Saginaw, Michigan.

Sponsor
Hera Biotech, Inc.
Study ID
NCT05698212
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 14, 2022
Status verified
Nov 2022
Primary completion
Mar 25, 2023
Completion
Apr 10, 2023

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Cohort 1
    Endometriosis diagnosed at stage 1 or 2
  • Active Comparator: Cohort 2
    Endometriosis diagnosed at stage 3 or 4
  • Other: Cohort 3
    Control--Not suspected of having and absence of endometriosis confirmed by diagnostic test. This group has uterine tissue biopsy and laparoscopy for non-endometriosis indication, i.e. tubal ligation

Primary Outcome Measure

Primary Outcome [ Time Frame: 1 week after laparoscopy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Valley OB-GYN Clinic, PCSaginawMichigan48602
Mackenzie Rittenberg
[email protected]
989-753-8453
Jackie Lang
[email protected]
989-753-8453
Jacqueline A Robinsons, MD (PRINCIPAL_INVESTIGATOR)
Corpus Christi Women's CenterCorpus ChristiTexas78412
Jessica Sanchez
[email protected]
361-851-5000
Monica Marroquin
[email protected]
361-851-5000
Charles R Kirkham, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Physician's Women's Center--Memorial CityHoustonTexas77024
Lori L Wink, MSN, NP
[email protected]
706-251-8339
Sandry Hurtago, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Saginaw, MI

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Valley OB-GYN Clinic, PC· Saginaw, MICorpus Christi Women's Center· Corpus Christi, TXUniversity of Texas Physician's Women's Center--Memorial City· Houston, TX

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