Histologic Comparison of Ablative Techniques for Endometr... | NCT06414083

Studies
Histologic Comparison of Ablative Techniques for Endometriosis

NCT06414083

Sponsor

TriHealth Inc.

Status

Recruiting

Last Update Posted

May 30, 2024Actual

Enrollment

141Estimated

Phase

Not Applicable

Conditions

Endometriosis
Endometriosis-related Pain
Endometriosis Pelvic
Endometriosis; Peritoneum

Interventions

Diathermy
CO2 Laser
Argon Beam Coagulator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2024Actual

Primary Completion Date

May 9, 2025Estimated

Completion Date

Jun 9, 2025Estimated

First Submitted Date

May 10, 2024

First Submission Date that Met QC Criteria

May 10, 2024

First Posted Date

May 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2024

Last Update Posted Date

May 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

141Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Diathermy	Active Comparator	Device: Diathermy
CO2 Laser	Active Comparator	Device: CO2 Laser
Argon Beam Coagulator	Active Comparator	Device: Argon Beam Coagulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diathermy	Device	Diathermy will be used to ablate the randomized sample.	Diathermy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Devin Namaky, MD	Contact	513-862-1888		devin_namaky@trihealth.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Good Samaritan Hospital	Recruiting	Cincinnati	Ohio	45220	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41525928	Derived	Namaky DD, Carrel-Lammert M, Hoehn J, Yeung J. Histologic Comparison of Ablative Techniques for Endometriosis: A Randomized Trial. J Minim Invasive Gynecol. 2026 Jan 10:S1553-4650(26)00044-0. doi: 10.1016/j.jmig.2026.01.020. Online ahead of print.

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 2, 2025			Apr 21, 2025	2
May 27, 2025

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D003972	Diathermy
D054020	Lasers, Gas

ID	Term
D006979	Hyperthermia, Induced
D013812	Therapeutics
D007834	Lasers
D055096	Optical Devices