NCT05698212

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Hera Biotech, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This study involves 2 visits to the site and possibly as outpatient surgical center, and the participant will be involved in the for as little as 1 day to as much as 60 days, mainly depending on scheduling of laparoscopy. Eligible participants in the active group will have history of endometriosis and will be having a laparoscopy for diagnosis within the next few weeks. Eligible participants in the control group will have no history of endometriosis but will need or have recently had a laparoscopy surgical procedure for a reasons such as tubal ligation. The participant will have an uterine biopsy (similar to a pap smear) in the physician's office before the laparoscopy. The biopsied tissue will be sent to a special lab for analysis and diagnosis of endometriosis by an innovative proprietary procedure that analyses the cells of the tissue collected in the biopsy. The results of the biopsy will be compared to the laparoscopy for accuracy.

Conditions

• Endometriosis
• Diagnosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MetriDx	Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record

Timeline

• Start date: 2022-09-14
• Primary completion: 2023-03-25
• Completion: 2023-04-10
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

3 sites across 1 country: United States