Histologic Comparison of Ablative Techniques for Endometriosis

TriHealth Inc.141 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

141

Conditions

Endometriosis Endometriosis-related Pain Endometriosis Pelvic Endometriosis; Peritoneum

Interventions

DiathermyDEVICE

Diathermy will be used to ablate the randomized sample.

CO2 LaserDEVICE

CO2 Laser will be used to ablate the randomized sample.

Argon Beam CoagulatorDEVICE

Argon Beam Coagulator will be used to ablate the randomized sample.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Good Samaritan Hospital

Cincinnati, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Positive Histology

Endometriosis seen on pathologic sample.

Time frame: 0 days

Secondary Outcomes

Pelvic Pain

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

Time frame: 3 months

Central Contacts

Devin Namaky, MD

CONTACT

513-862-1888 devin_namaky@trihealth.com

Data from ClinicalTrials.gov

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