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

Recruiting now · Phase 2

Conditions studied: Endometriosis, Diagnosis

In brief

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 facts

Study ID

NCT05698212

Run by

Hera Biotech, Inc.

People needed

75

Starts

2022-09-14

Expected to finish

2023-04-10

Last updated by the study team

2023-01-26

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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