Histologic Comparison of Ablative Techniques for Endometriosis

Not Applicable

Recruiting

• Conditions: Endometriosis; Peritoneum; Endometriosis-related Pain; Endometriosis; Endometriosis Pelvic
• Interventions: Device: Diathermy; Device: CO2 Laser; Device: Argon Beam Coagulator

• Registration Number: NCT06414083
• Lead Sponsor: TriHealth Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-09
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-05-09
• Study Completion: 2025-06-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diathermy	Diathermy	-
CO2 Laser	CO2 Laser	-
Argon Beam Coagulator	Argon Beam Coagulator	-

Primary Outcome Measures

Name	Time	Method
Positive Histology	0 days	Endometriosis seen on pathologic sample.

Secondary Outcome Measures

Name	Time	Method
Pelvic Pain	3 months	Pre-operative and Post-operative Pelvic Pain Visual Analog Scale. Minimum Score 0. Maximum Score 100. Higher score is worse outcome.

Trial Locations

Locations (1)

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States