RecruitingEndometriosisDiagnosis
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
Eligible age
18–50 yrs
Accepts
Women
Locations
2 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this 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.
Sponsor: Hera Biotech, Inc.
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.
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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05698212 · last updated 2023-01-26