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NCT06414083 Clinical Trial

Histologic Comparison of Ablative Techniques for Endometriosis

Endometriosis Clinical Trial

Official title:
Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06414083
Other study ID # 24-007
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 9, 2024
Est. completion date June 9, 2025

Study information
Verified date May 2024
Source TriHealth Inc.
Contact Devin Namaky, MD
Phone 513-862-1888
Email devin_namaky@trihealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 141
Est. completion date June 9, 2025
Est. primary completion date May 9, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Diathermy
Diathermy will be used to ablate the randomized sample.
• CO2 Laser
CO2 Laser will be used to ablate the randomized sample.
• Argon Beam Coagulator
Argon Beam Coagulator will be used to ablate the randomized sample.

Locations
Country Name City State
United States Good Samaritan Hospital Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positive Histology Endometriosis seen on pathologic sample. 0 days
Secondary Pelvic Pain Pre-operative and Post-operative Pelvic Pain Visual Analog Scale. Minimum Score 0. Maximum Score 100. Higher score is worse outcome. 3 months
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