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Completed
NCT05272046
Monopolar and Bipolar Current RFA Knife in POEM
Conditions: Esophageal Motility Disorders
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 104
Sponsor: Baylor College of Medicine
Location: Baylor College of Medicine Houston Texas
Summary
Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. The procedure is typically completed using standard monopolar energy, which are effective, but can be associated with post-procedural pain. More importantly, frequent exchange of various instruments are required in order to cut the right layers and to stop bleeding. The Speedboat-RSD is FDA approved for dissection of various tissue within the gastrointestinal tract tract but only a few studies have evaluated its use in POEM. Currently, the investigators have been performing EGD with POEM procedures using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post procedural pain.
Eligibility Criteria
Inclusion Criteria:
* Age greater than or equal to 18 years of age
* Able to sign consent - Planned POEM procedure for all indications
Exclusion Criteria:
* Pregnant patients
* Prisoners
* Unable to sign consent
Source: ClinicalTrials.gov (NCT05272046). StuddyBuddy aggregates publicly available trial information.