NCT06414083RecruitingNot Applicable
Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- TriHealth Inc.
- Enrollment
- 141
- Locations
- 2
- Primary Endpoint
- Positive Histology
Study Overview
Brief Summary
To our knowledge, no other human studies directly compare the effectiveness of the various ablative technologies. We set out to design a study to directly compare ablative energy sources and evaluate their ability to destroy native endometriosis tissue in humans.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Pathologist is blinded to treatment arm
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult women 18 years of age or older
- •Already planning to undergo scheduled robotic assisted or laparoscopic excision of lesions for pelvic pain symptoms (pelvic pain, dysmenorrhea, dyspareunia, dysuria, dyschezia, ovarian pain) or endometriosis of any kind (endometriosis of any location, or endometrioma)
Exclusion Criteria
- •Known pregnancy at enrollment or at the time of the excision surgery
Outcomes
Primary Outcomes
Positive Histology
Time Frame: 0 days
Endometriosis seen on pathologic sample.
Secondary Outcomes
- Pelvic Pain(3 months)
Investigators
Study Sites (2)
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