Histologic Comparison of Ablative Techniques for Endometriosis

Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial

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 Overview

• Status: Recruiting
• Conditions: Endometriosis; Endometriosis-related Pain; Endometriosis; Peritoneum; Endometriosis Pelvic
• Intervention / Treatment: Device: Diathermy; Device: CO2 Laser; Device: Argon Beam Coagulator

• Study Type: Interventional
• Enrollment (Estimated): 141
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devin Namaky, MD; Phone Number: 513-862-1888; Email: devin_namaky@trihealth.com

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Recruiting
      • Good Samaritan Hospital
      • Contact: Devin Namaky, MD; Phone Number: 513-862-1888; Email: devin_namaky@trihealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diathermy	Device: Diathermy; Diathermy will be used to ablate the randomized sample.
Active Comparator: CO2 Laser	Device: CO2 Laser; CO2 Laser will be used to ablate the randomized sample.
Active Comparator: Argon Beam Coagulator	Device: Argon Beam Coagulator; Argon Beam Coagulator will be used to ablate the randomized sample.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Histology	Endometriosis seen on pathologic sample.	0 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): May 9, 2025
• Study Completion (Estimated): June 9, 2025

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 24-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes