Monopolar and Bipolar Current RFA Knife in POEM

Not Applicable

Active, not recruiting

• Conditions: Esophageal Motility Disorders
• Interventions: Procedure: Per-oral Endoscopic Myotomy; Device: Speedboat (Bipolar electrocautery knife)

• Registration Number: NCT05272046
• Lead Sponsor: Baylor College of Medicine

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 Timeline

• Study First Submitted: 2022-02-04
• Study Start: 2022-02-22
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2025-02-19
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar Electrocautery tool	Per-oral Endoscopic Myotomy	Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.
Bipolar Electrocautery tool	Speedboat (Bipolar electrocautery knife)	Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.
Monopolar Electrocautery tool	Per-oral Endoscopic Myotomy	Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure.

Primary Outcome Measures

Name	Time	Method
Change in pain score	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 Outcome Measures

Name	Time	Method
Total procedure time (minutes)	Day 1	Includes time from incision, tunneling, dissection and closure.
Study knife removal during procedure	Day 1	Total number of times the Speedboat knife needed to be removed for another device during mucosal incision, submucosal dissection, or myotomy.
Hospital Length-of-stay	Up to 1 week	Number of days patient remains in hospital following procedure
Adverse events	1 month, 3 months, 6 months, and 12 months.	Collection of unanticipated medical occurrences within a 12 month time frame.
Technical success rate of patients who completed POEM procedure with the bipolar knife.	Day 1	Completion of POEM procedure with the Speedboat-RS2 knife

Trial Locations

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