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Lab-developed Test
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
Phase 2
Waitlist Available
Led By Sandra M Hurtado, MD
Research Sponsored by Hera Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after laparoscopy
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to diagnose endometriosis using a small tissue sample from the uterus, analyzed by advanced computer technology. It targets women undergoing surgery for endometriosis or other reasons. The goal is to find a less invasive diagnostic method by comparing the tissue sample results with surgical findings.
Eligible Conditions
- Endometriosis
- Diagnosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week after laparoscopy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after laparoscopy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Secondary study objectives
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 3Experimental Treatment1 Intervention
Control--Not suspected of having and absence of endometriosis confirmed by diagnostic test.
This group has uterine tissue biopsy and laparoscopy for non-endometriosis indication, i.e. tubal ligation
Group II: Cohort 2Active Control1 Intervention
Endometriosis diagnosed at stage 3 or 4
Group III: Cohort 1Active Control1 Intervention
Endometriosis diagnosed at stage 1 or 2
Find a Location
Who is running the clinical trial?
Hera Biotech, Inc.Lead Sponsor
Sandra M Hurtado, MDPrincipal InvestigatorUniversity of Texas Physicians Women's Center
Jacqueline A Robinson, MDPrincipal InvestigatorValley OB-GYN Clinic
Charles R Kirkham, MDPrincipal InvestigatorCorpus Christi Women's Clinic