Endometriosis, Endometriosis-related Pain, Endometriosis Pelvic, Endometriosis; Peritoneum
Conditions
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.
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.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Pathologist is blinded to treatment arm
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* Known pregnancy at enrollment or at the time of the excision surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Histology | 0 days | Endometriosis seen on pathologic sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Pain | 3 months | Pre-operative and Post-operative Pelvic Pain Visual Analog Scale. Minimum Score 0. Maximum Score 100. Higher score is worse outcome. |
Countries
United States
Contacts
Primary ContactDevin Namaky, MD
Outcome results
None listed