Histologic Comparison of Ablative Techniques for Endometriosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTriHealth Inc.
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Known pregnancy at enrollment or at the time of the excision surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Diathermy
DeviceDiathermy will be used to ablate the randomized sample.
CO2 Laser
DeviceCO2 Laser will be used to ablate the randomized sample.
Argon Beam Coagulator
DeviceArgon Beam Coagulator will be used to ablate the randomized sample.
Treatment groups
141 Participants
are divided into 3 treatment groupsGroup A: DiathermyActive comparator 1 intervention
Group B: CO2 LaserActive comparator 1 intervention
Group C: Argon Beam CoagulatorActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Positive Histology
Endometriosis seen on pathologic sample.
Time frame
0 daysSecondary 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 monthsSponsors and contacts
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Source ClinicalTrials.gov