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

RecruitingPhase 2Healthy volunteers welcome

Proof-of-Concept, Obs Study to Evaluate Accuracy of MetriDx Lab Developed Test (LDT) to Accurately Identify Endometriosis-specific Biological Markers Using Micro-fluidic Analysis of Cells Enabling Clinicians to Diagnose Endometriosis

Who can join

Ages 18 to 50 · Women · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* Able to understand and provide informed consent.
* Natural born female of childbearing potential.
* Age between 18 and 50, inclusive.
* Not pregnant at Visit 0 (screening) or Visit 1 (day of procedure).
* Free of systemic or pelvic disorder that, in the opinion of the investigator, may interfere with the tissue collection procedure, analysis of the tissue or increase the risk to subject.
* Must not have received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
* For Cohort 1 and 2:

  * Suspected of having endometriosis, or previously diagnosed with endometriosis, and currently recommended for laparoscopic surgery by physician.
  * Must have laparoscopic surgery within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day), or a laparoscopy on record within the 12 months prior to Visit 0 for diagnosis only.
  * Surgical report from prior laparoscopy must indicate that endometriosis was not treated with surgical ablation or excision.
  * Subjects will be assigned to Cohort 1 or 2 based on diagnosis and staging results from laparoscopy.
* Or for Cohort 3:

  * Not suspected of having endometriosis
  * no previous diagnosis or symptoms of endometriosis, who have had a laparoscopy for another reason, such as tubal ligation or other abdominal procedure, within the past 12 months prior to screening Visit 0,
  * or laparoscopy to be completed within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day).
  * Surgeon's report must have no supplemental observations of endometriosis lesions or diagnosis. Subjects will be assigned to Cohort 3.

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.
* History of reproductive cancer.
* Has a condition that, in the opinion of the investigator, would confound tissue collection or analysis.
* Has an active pelvic infection or other infections contra-indicated for laparoscopy.
* Has participated in any interventional clinical trial in the previous 90 days in which an investigational drug was administered.
* Has a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past two years.

About the study

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.

What is being tested

Sponsor: Hera Biotech, Inc. · Participants: 75 · Started: Sep 14, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05698212

Locations in the U.S.

MichiganValley OB-GYN Clinic, PC, Saginaw (Not yet recruiting)
TexasCorpus Christi Women's Center, Corpus Christi
University of Texas Physician's Women's Center--Memorial City, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.