Monopolar and Bipolar Current RFA Knife in POEM

NCT05272046 | Active Not Recruiting FDA Device

• 1 other identifier: H-50587
• Study Type: interventional
• Target: 105
• Locations: 3 countries
• Sites: 3

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.

Conditions

Esophageal Motility Disorders

Keywords

Achalasia; Dysphagia; Per-Oral Endoscopic Myotomy; Bipolar electrocautery

Outcome Measures

Primary Outcomes (1)

• Change in pain score

  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.

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

Secondary Outcomes (5)

• Technical success rate of patients who completed POEM procedure with the bipolar knife.

  Day 1

• Total procedure time (minutes)

  Day 1

• Study knife removal during procedure

  Day 1

• Hospital Length-of-stay

  Up to 1 week

• Adverse events

  1 month, 3 months, 6 months, and 12 months.

Study Arms (2)

Monopolar Electrocautery tool

ACTIVE COMPARATOR

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

Procedure: Per-oral Endoscopic Myotomy

Bipolar Electrocautery tool

EXPERIMENTAL

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

Procedure: Per-oral Endoscopic Myotomy; Device: Speedboat (Bipolar electrocautery knife)

Interventions

Speedboat (Bipolar electrocautery knife) DEVICE

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

Also known as: Speedboat Inject

Bipolar Electrocautery tool

Per-oral Endoscopic Myotomy PROCEDURE

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

Also known as: POEM

Bipolar Electrocautery tool; Monopolar Electrocautery tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant patients
• Prisoners
• Unable to sign consent

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (3)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Asian Institute of Gastroenterology (AIG) Hospitals

Hyderabad, 500082, India

Location

Navarra Hospital Complex - Navarra Hospital

Pamplona, 31008, Spain

Location

Related Publications (3)

• Jung D, Youn YH, Jahng J, Kim JH, Park H. Risk of electrocoagulation syndrome after endoscopic submucosal dissection in the colon and rectum. Endoscopy. 2013 Sep;45(9):714-7. doi: 10.1055/s-0033-1344555. Epub 2013 Aug 29.

  PMID: 23990482 BACKGROUND

• Saunders B P, Tsiamoulos Z P, Bourikas L et al.The

  BACKGROUND

• Patil G, Dalal A, Maydeo AP. Feasibility of Speedboat RS2 with bipolar radiofrequency energy for peroral endoscopic myotomy in patients with achalasia (with video). Endosc Int Open. 2020 Aug;8(8):E998-E1001. doi: 10.1055/a-1165-0087. Epub 2020 Jul 21.

  PMID: 32743048 BACKGROUND

MeSH Terms

Conditions

Esophageal Motility Disorders; Esophageal Achalasia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will not know which electrocautery tool will be used in their procedure.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: Two groups with patients randomized into receiving either the standard of care bipolar electrocautery tool or monopolar electrocautery tool.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 9, 2022
• Study Start: February 22, 2022
• Primary Completion (Estimated): November 19, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IN (1); ES (1)