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MetriDx Test for Endometriosis Diagnosis

This study is testing a new way to diagnose endometriosis without surgery. It uses a test called MetriDx, which analyzes a small tissue sample from your uterus (similar to a Pap smear). This could potentially replace the need for a laparoscopy (a surgical procedure to look inside your abdomen) for diagnosis. The study is looking for women aged 18 to 50 who are able to understand and agree to participate. Some participants will have a history of endometriosis and be scheduled for a laparoscopy, while others will have no history of endometriosis but are having a laparoscopy for other reasons. The goal is to see how accurately MetriDx can identify endometriosis compared to the results from a laparoscopy.

Study design
This interventional study plans to enroll 75 women. It compares the MetriDx test results to laparoscopy reports.
What's involved
You would have two visits, including an office visit for a uterine biopsy before your laparoscopy. Your participation could last from 1 to 60 days.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 1 week after laparoscopy.

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NCT05698212

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

Recruiting
PHASE2Ages 18–50InterventionalDiagnostic
Hera Biotech, Inc.
~75 participants
Updated 2023-01-26 on ClinicalTrials.gov
What's tested:MetriDx

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome
Measured over 1 week after laparoscopy

Conditions

Endometriosis
Diagnosis

Explore related trials

Endometriosis

Where it's being run

3 sites across 2 states
Texas2
Michigan1

Study leadership

  • Sandra M Hurtado, MD · PRINCIPAL_INVESTIGATOR · University of Texas Physicians Women's Center
  • Charles R Kirkham, MD · PRINCIPAL_INVESTIGATOR · Corpus Christi Women's Clinic
  • Jacqueline A Robinson, MD · PRINCIPAL_INVESTIGATOR · Valley OB-GYN Clinic

Who to contact

Janan Van Osdell, MHSA
[email protected]
855-826-6638 · ext. 102
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Primary Outcome1 week after laparoscopy

    Endometriosis diagnosis