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RecruitingNCT06414083Updated May 30, 2024

Histologic Comparison of Ablative Techniques for Endometriosis

An interventional study of Diathermy and CO2 Laser in Endometriosis, Endometriosis-related Pain and Endometriosis Pelvic, sponsored by TriHealth Inc.. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.

Sponsored by TriHealth Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
141
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Endometriosis
  • Endometriosis-related Pain
  • Endometriosis Pelvic
  • Endometriosis; Peritoneum

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's planned enrollment of 141 is above the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Known pregnancy at enrollment or at the time of the excision surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
141 participants (estimated)

Study arms

  • Active comparator
    Diathermy

    Device: Diathermy

  • Active comparator
    CO2 Laser

    Device: CO2 Laser

  • Active comparator
    Argon Beam Coagulator

    Device: Argon Beam Coagulator

Interventions

  • DeviceDiathermy

    Diathermy will be used to ablate the randomized sample.

  • DeviceCO2 Laser

    CO2 Laser will be used to ablate the randomized sample.

  • DeviceArgon Beam Coagulator

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

06

What researchers measure

Primary outcomes

  1. Positive Histology

    Endometriosis seen on pathologic sample.

    Time frame: 0 days

Secondary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Good Samaritan Hospital
    Cincinnati, Ohio 45220, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06414083
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
May 16, 2024
Start date
May 9, 2024
Primary completion
May 9, 2025 (estimated)
Completion
Jun 9, 2025 (estimated)
Last update
May 30, 2024

Study contacts

Devin Namaky, MD
Contact
devin_namaky@trihealth.com
513-862-1888

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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