NCT06414083

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2025

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 10, 2024

Last Update Submit

May 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Positive Histology

    Endometriosis seen on pathologic sample.

    0 days

Secondary Outcomes (1)

  • Pelvic Pain

    3 months

Study Arms (3)

Diathermy

ACTIVE COMPARATOR
Device: Diathermy

CO2 Laser

ACTIVE COMPARATOR
Device: CO2 Laser

Argon Beam Coagulator

ACTIVE COMPARATOR
Device: Argon Beam Coagulator

Interventions

DiathermyDEVICE

Diathermy will be used to ablate the randomized sample.

Diathermy
CO2 LaserDEVICE

CO2 Laser will be used to ablate the randomized sample.

CO2 Laser

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

Argon Beam Coagulator

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Known pregnancy at enrollment or at the time of the excision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Endometriosis

Interventions

DiathermyLasers, Gas

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeuticsLasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Pathologist is blinded to treatment arm
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 16, 2024

Study Start

May 9, 2024

Primary Completion

May 9, 2025

Study Completion

June 9, 2025

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations