Monopolar and Bipolar Current RFA Knife in POEM

Last updated: March 28, 2024
Sponsor: Baylor College of Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Esophageal Disorders

Treatment

Per-oral Endoscopic Myotomy

Speedboat (Bipolar electrocautery knife)

Clinical Study ID

NCT05272046
H-50587
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age greater than or equal to 18 years of age
  • Able to sign consent - Planned POEM procedure for all indications

Exclusion

Exclusion Criteria:

  • Pregnant patients
  • Prisoners
  • Unable to sign consent

Study Design

Total Participants: 105
Treatment Group(s): 2
Primary Treatment: Per-oral Endoscopic Myotomy
Phase:
Study Start date:
February 22, 2022
Estimated Completion Date:
April 01, 2025

Study Description

Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal motility disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissection of the esophageal submucosa followed by cutting of the esophageal muscle. The procedure is typically completed using standard monopolar cutting knives, which are effective, but can be associated with inadvertent thermal injury and post-procedural pain due to dissemination of higher voltage. More importantly, frequent exchange of various instruments are required in order to inject within the submucosa and to coagulate bleeding vessels. The Speedboat-RSD has an integrated injection needle for submucosal injection and uses bipolar radiofrequency energy (BRF) and microwave energy to dissect tissue/coagulate vessels. In essence, injection, submucosal dissection, cutting, and coagulation can all occur with one knife (2). It is FDA approved for submucosal dissection (ESD) and myotomy within the gastrointestinal tract but only a few studies have evaluated its use in POEM (3). Currently, the investigators have been performing EGD with the POEM procedure 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 related pain.

Connect with a study center

  • Asian Institute of Gastroenterology (AIG) Hospitals

    Hyderabad, 500082
    India

    Site Not Available

  • Navarra Hospital Complex - Navarra Hospital

    Pamplona, 31008
    Spain

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

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