Monopolar and Bipolar Current RFA Knife in POEM

March 28, 2024 updated by: Salmaan Azam Jawaid, MD, Baylor College of Medicine

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Hyderabad, India, 500082
        • Asian Institute of Gastroenterology (AIG) Hospitals
  • Spain
      • Pamplona, Spain, 31008
        • Navarra Hospital Complex - Navarra Hospital
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Monopolar Electrocautery tool
Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure.
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.
Other Names:
  • POEM
Experimental: Bipolar Electrocautery tool
Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.
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.
Other Names:
  • POEM
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.
Other Names:
  • Speedboat Inject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-procedure, 1-hour post procedure, 8-10 hours post procedure, and 24 hours post procedure.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Estimated)

February 19, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-50587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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