Histologic Comparison of Ablative Techniques for Endometriosis: A Randomized Trial.
Devin D Namaky, Meredith Carrel-Lammert, Jonathan Hoehn...
https://pubmed.ncbi.nlm.nih.gov/41525928Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID06414083
Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial
Led by TriHealth Inc. · Updated on 2024-05-30
141
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized trial to directly compare different ablative technologies used to destroy native endometriosis tissue in women. The study aims to evaluate the effectiveness of three ablative devices: Diathermy, CO2 Laser, and Argon Beam Coagulator. This trial is sponsored by TriHealth Inc. and focuses on women with endometriosis or related pelvic pain symptoms. Participants will receive one of the three ablative treatments randomly applied during scheduled robotic-assisted or laparoscopic surgery to remove endometriosis lesions. Each device is used to ablate the targeted tissue during the procedure. The study does not include a placebo group and uses a single-blind design. Throughout the study, researchers will assess the tissue samples immediately after ablation to confirm destruction (positive histology) and follow participants for three months to evaluate changes in pelvic pain. The total participation includes the surgery day and follow-up pain assessments, ensuring careful monitoring of outcomes related to endometriosis treatment.
CONDITIONS
Brief Title
Histologic Comparison of Ablative Techniques for Endometriosis
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Known pregnancy at enrollment or at the time of the excision surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of surgery
Participants undergo ablation of endometriosis lesions using one of three randomized device techniques: Diathermy, CO2 Laser, or Argon Beam Coagulator during scheduled robotic assisted or laparoscopic excision surgery.
1 visit (in-person)
Post-operative Follow-up
Duration - 3 months
Participants are followed up to assess pelvic pain and recovery after the ablation procedure.
1 follow-up visit at 3 months
Trial Site Locations
Total: 1 location
1
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
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Research Team
D
Devin Namaky, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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