Monopolar and Bipolar Current RFA Knife in POEM

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Motility Disorders

Intervention / Treatment
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* Procedure: Per-oral Endoscopic Myotomy
* Device: Speedboat (Bipolar electrocautery knife)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups with patients randomized into receiving either the standard of care bipolar electrocautery tool or monopolar electrocautery tool.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monopolar Electrocautery tool<br>Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure. | Procedure: Per-oral Endoscopic Myotomy<br>* Therapeutic endoscopy procedure by means of electrocautery surgical tools for treatment of various esophageal conditions such as achalasia or spastic esophageal disorders.<br>* Other names: POEM;|
| Experimental: Bipolar Electrocautery tool<br>Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure. | Procedure: Per-oral Endoscopic Myotomy<br>* Therapeutic endoscopy procedure by means of electrocautery surgical tools for treatment of various esophageal conditions such as achalasia or spastic esophageal disorders.<br>* Other names: POEM;Device: Speedboat (Bipolar electrocautery knife)<br>* Use of Creo Medical's Speedboat RS2 knife and generator in performing the POEM procedure for patients presenting with an esophageal motility disorder.<br>* Other names: Speedboat Inject;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate of patients who completed POEM procedure with the bipolar knife. | Completion of POEM procedure with the Speedboat-RS2 knife | Day 1 | 
| Total procedure time (minutes) | Includes time from incision, tunneling, dissection and closure. | Day 1 | 
| 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 | 
| Hospital Length-of-stay | Number of days patient remains in hospital following procedure | Up to 1 week | 
| Adverse events | Collection of unanticipated medical occurrences within a 12 month time frame. | 1 month, 3 months, 6 months, and 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achalasia, Dysphagia, Per-Oral Endoscopic Myotomy, Bipolar electrocautery