Skip to main content
Clinical Trials/NCT06414083
NCT06414083RecruitingNot Applicable

Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial

TriHealth Inc.2 sites in 1 country141 target enrollmentStarted: May 9, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Histologic Comparison of Ablative... | Clinical Trial