Monopolar and Bipolar Current RFA Knife in POEM

NCT ID: NCT05272046

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2025-04-01

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.

Conditions

Esophageal Motility Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Monopolar Electrocautery tool

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

Group Type: ACTIVE_COMPARATOR

Per-oral Endoscopic Myotomy

Intervention Type: PROCEDURE

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

Bipolar Electrocautery tool

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

Group Type: EXPERIMENTAL

Per-oral Endoscopic Myotomy

Intervention Type: PROCEDURE

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

Speedboat (Bipolar electrocautery knife)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

POEM; Speedboat Inject

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Salmaan Azam Jawaid, MD

Principal Investigator, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Asian Institute of Gastroenterology (AIG) Hospitals

Hyderabad, , India

Navarra Hospital Complex - Navarra Hospital

Pamplona, , Spain

Countries

United States; India; Spain

References

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.

Reference Type: BACKGROUND

PMID: 23990482 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 32743048 (View on PubMed)

Other Identifiers

H-50587

Identifier Type: -

Identifier Source: org_study_id