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Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
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
- MetriDx (diagnostic test)
Sponsor: Hera Biotech, Inc. · Participants: 75 · Started: Sep 14, 2022
Contact the study team
- Janan Van Osdell, MHSA · Phone: 855-826-6638
- Somer Baburek, MBA · Phone: 210-683-1069
Official record on ClinicalTrials.gov — NCT05698212
Locations in the U.S.
| Michigan | Valley OB-GYN Clinic, PC, Saginaw (Not yet recruiting) |
| Texas | Corpus 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.