EndometriosisNCT06414083
Histologic Comparison of Ablative Techniques for Endometriosis
A study testing Diathermy, CO2 Laser and Argon Beam Coagulator in people with Endometriosis and Endometriosis-related Pain, run by TriHealth Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Endometriosis-related Pain, Endometriosis Pelvic
- What is being tested?
- Diathermy, CO2 Laser and Argon Beam Coagulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2024to 9 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Known pregnancy at enrollment or at the time of the excision surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Devin Namaky, MD, 513-862-1888, devin_namaky@trihealth.com
About this study
Official title: Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial
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
- Being tested
- Diathermy, CO2 Laser, Argon Beam Coagulator
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Diathermy | Active comparator | Not described Receives: Device: Diathermy |
| CO2 Laser | Active comparator | Not described Receives: Device: CO2 Laser |
| Argon Beam Coagulator | Active comparator | Not described Receives: Device: Argon Beam Coagulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Histology
Endometriosis seen on pathologic sample.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start9 May 2024
- Primary completion9 May 2025 (estimated)
- Study completion9 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414083
- Sponsor's protocol ID
- 24-007
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41525928
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial
- ClinicalTrials.gov ID
- NCT06414083
- Acronym / sponsor ID
- 24-007
- Conditions
- Endometriosis, Endometriosis-related Pain, Endometriosis Pelvic, Endometriosis; Peritoneum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- 9 May 2025 (estimated)
- Study completion
- 9 Jun 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diathermy | Active comparator | Device: Diathermy |
| CO2 Laser | Active comparator | Device: CO2 Laser |
| Argon Beam Coagulator | Active comparator | Device: Argon Beam Coagulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Known pregnancy at enrollment or at the time of the excision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiathermyDiathermy will be used to ablate the randomized sample. | Device | Diathermy |
| CO2 LaserCO2 Laser will be used to ablate the randomized sample. | Device | CO2 Laser |
| Argon Beam CoagulatorArgon Beam Coagulator will be used to ablate the randomized sample. | Device | Argon Beam Coagulator |
Primary outcome
Positive Histology
Time frame: 0 days
Endometriosis seen on pathologic sample.
1 secondary outcome
Pelvic Pain
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 41525928Namaky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diathermy, CO2 Laser and Argon Beam Coagulator in people with Endometriosis and Endometriosis-related Pain, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devin Namaky, MD (513-862-1888, devin_namaky@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Histology (time frame: 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06414083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.