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Clinical Trials/NCT05272046
NCT05272046CompletedNot Applicable

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

Baylor College of Medicine6 sites in 3 countries104 target enrollmentStarted: February 22, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
104
Locations
6
Primary Endpoint
Change in pain score

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

Patient will not know which electrocautery tool will be used in their procedure.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Bipolar Electrocautery tool

Experimental

Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.

Intervention: Speedboat (Bipolar electrocautery knife) (Device)

Monopolar Electrocautery tool

Active Comparator

Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure.

Intervention: Per-oral Endoscopic Myotomy (Procedure)

Bipolar Electrocautery tool

Experimental

Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.

Intervention: Per-oral Endoscopic Myotomy (Procedure)

Outcomes

Primary Outcomes

Change in pain score

Time Frame: Pre-procedure, 1-hour post procedure, 8-10 hours post procedure, and 24 hours post procedure.

Use of a Visual Analog Scale (VAS) from 0-10 with "0" being no pain and "10" being the worse pain to assess overall pain following the POEM procedure up to 24 hours.

Secondary Outcomes

  • Study knife removal during procedure(Day 1)
  • Total procedure time (minutes)(Day 1)
  • Hospital Length-of-stay(Up to 1 week)
  • Adverse events(1 month, 3 months, 6 months, and 12 months.)
  • Technical success rate of patients who completed POEM procedure with the bipolar knife.(Day 1)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Salmaan Azam Jawaid, MD

Principal Investigator, Assistant Professor

Baylor College of Medicine

Study Sites (6)

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