🏛️ Verified NIH Record • Updated 2023-01-24

Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers (NCT05698212)

🟢 Recruiting Phase2 📋 Clinical Research Protocol Sponsor: Hera Biotech, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (17 items).

Location: Valley OB-GYN Clinic, PC — Saginaw, Michigan

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Younger than 18 or 51 years or older.
  • Surgical history of hysterectomy.
  • Has received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
  • Cohort 3: Prior diagnosis of endometriosis, or surgical note from prior laparoscopy that indicates endometriosis lesions were observed.
  • Has a BMI 40 or above.
  • Is currently taking a blood thinner medication.
  • Currently, pregnant, breast feeding, or has given birth in the last 6 months.
  • Diagnosed with HIV, AIDS, hepatitis A, B, or C, or has active malignancy.
  • Has a complicating condition that would pose a hazard to tissue handling.
  • Undergoing fertility or hormone therapy treatments.
  • History or evidence of uterine fibroids.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

  • Valley OB-GYN Clinic, PC — Saginaw, Michigan
  • Corpus Christi Women's Center — Corpus Christi, Texas
  • University of Texas Physician's Women's Center--Memorial City — Houston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗