Monopolar and Bipolar Current RFA Knife in POEM

Esophageal Motility Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05272046
• Other study ID #: H-50587
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: April 1, 2025
• Est. primary completion date: February 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse

Intervention

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

Country	Name	City	State
India	Asian Institute of Gastroenterology (AIG) Hospitals	Hyderabad
Spain	Navarra Hospital Complex - Navarra Hospital	Pamplona
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Countries where clinical trial is conducted

United States,  India,  Spain, 

References & 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. — View Citation

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. — View Citation

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

Outcome

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