Recruiting

Ablative Techniques

Sponsor:

TriHealth Inc.

Code:

NCT06414083

Conditions

Endometriosis

Endometriosis-related Pain

Endometriosis Pelvic

Endometriosis; Peritoneum

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diathermy

CO2 Laser

Argon Beam Coagulator

Study Details

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.

Conditions

Endometriosis

Endometriosis-related Pain

Endometriosis Pelvic

Endometriosis; Peritoneum

Study ID

NCT06414083

Start date

May 9, 2024

Status verified date

May, 2024

Completion date

Jun 9, 2025

Anticipated

Primary completion date

May 9, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Diathermy

active comparator: CO2 Laser

active comparator: Argon Beam Coagulator

Interventions

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.

Primary outcome measure

  • Positive Histology [ Time Frame: 0 days ]

Central Contacts and Locations

Central contacts

Devin Namaky, MD

513-862-1888devin_namaky@trihealth.com

Locations

Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Devin Namaky, MD

513-862-1888devin_namaky@trihealth.com

More Information

Sponsor

TriHealth Inc.

Last update posted

May 30, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TriHealth Inc. on 2024-05-30.