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Completed

NCT Number: NCT05272046

Monopolar and Bipolar Current RFA Knife in POEM

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Institute of Gastroenterology (AIG) Hospitals, Hyderabad, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: POEM

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.

Other names: Speedboat Inject

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Total procedure time (minutes)

    Time frame: Day 1

    Includes time from incision, tunneling, dissection and closure.

  3. 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.

  4. Hospital Length-of-stay

    Time frame: Up to 1 week

    Number of days patient remains in hospital following procedure

  5. Adverse events

    Time frame: 1 month, 3 months, 6 months, and 12 months.

    Collection of unanticipated medical occurrences within a 12 month time frame.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 9, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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