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ACTIVE NOT RECRUITING
NCT05272046
NA

Monopolar and Bipolar Current RFA Knife in POEM

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

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.

Official title: Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in POEM (Per-Oral Endoscopic Myotomy)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2022-02-22

Completion Date

2026-12-01

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

PROCEDURE

Per-oral Endoscopic Myotomy

Therapeutic endoscopy procedure by means of electrocautery surgical tools for treatment of various esophageal conditions such as achalasia or spastic esophageal disorders.

DEVICE

Speedboat (Bipolar electrocautery knife)

Use of Creo Medical's Speedboat RS2 knife and generator in performing the POEM procedure for patients presenting with an esophageal motility disorder.

Locations (3)

Baylor College of Medicine

Houston, Texas, United States

Asian Institute of Gastroenterology (AIG) Hospitals

Hyderabad, India

Navarra Hospital Complex - Navarra Hospital

Pamplona, Spain