Actively Recruiting
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
Led by Hera Biotech, Inc. · Updated on 2023-01-26
75
Participants Needed
3
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent.
- Natural born female of childbearing potential.
- Age between 18 and 50, inclusive.
- Not pregnant at screening or day of procedure.
- Free of systemic or pelvic disorders that could interfere with tissue collection or increase risk.
- No excision or ablation surgery or treatment for endometriosis within past 12 months.
- For Cohorts 1 and 2: suspected or diagnosed endometriosis and recommended for laparoscopy within 60 days after screening or laparoscopy within past 12 months for diagnosis only, with no surgical treatment of endometriosis.
- For Cohort 3: no suspicion or diagnosis of endometriosis, laparoscopy for other reasons within past 12 months or planned within 60 days, with no endometriosis observed in surgical reports.
You will not qualify if you...
- Younger than 18 or 51 years or older.
- History of hysterectomy.
- Received excision or ablation surgery or treatment for endometriosis within past 12 months.
- For Cohort 3: prior diagnosis of endometriosis or surgical note indicating endometriosis lesions.
- Body mass index (BMI) of 40 or above.
- Currently taking blood thinner medication.
- Currently pregnant, breastfeeding, or gave birth in last 6 months.
- Diagnosed with HIV, AIDS, hepatitis A, B, or C, or active malignancy.
- Conditions posing hazard to tissue handling.
- Undergoing fertility or hormone therapy.
- History or evidence of uterine fibroids.
- History of reproductive cancer.
- Conditions that would confound tissue collection or analysis.
- Active pelvic or other infections contraindicating laparoscopy.
- Participation in interventional drug trial in past 90 days.
- History or suspicion of alcohol or illegal drug/substance abuse in past two years.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Valley OB-GYN Clinic, PC
Saginaw, Michigan, United States, 48602
Not Yet Recruiting
2
Corpus Christi Women's Center
Corpus Christi, Texas, United States, 78412
Actively Recruiting
3
University of Texas Physician's Women's Center--Memorial City
Houston, Texas, United States, 77024
Actively Recruiting
Research Team
J
Janan Van Osdell, MHSA
CONTACT
S
Somer Baburek, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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