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Monopolar and Bipolar Current RFA Knife in POEM

Primary Purpose

Esophageal Motility Disorders

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Per-oral Endoscopic Myotomy
Speedboat (Bipolar electrocautery knife)
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Esophageal Motility Disorders focused on measuring Achalasia, Dysphagia, Per-Oral Endoscopic Myotomy, Bipolar electrocautery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of MedicineRecruiting
  • Asian Institute of Gastroenterology (AIG) HospitalsRecruiting
  • Navarra Hospital Complex - Navarra HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monopolar Electrocautery tool

Bipolar Electrocautery tool

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Technical success rate of patients who completed POEM procedure with the bipolar knife.
Completion of POEM procedure with the Speedboat-RS2 knife
Total procedure time (minutes)
Includes time from incision, tunneling, dissection and closure.
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.
Hospital Length-of-stay
Number of days patient remains in hospital following procedure
Adverse events
Collection of unanticipated medical occurrences within a 12 month time frame.

Full Information

First Posted
February 4, 2022
Last Updated
March 23, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05272046
Brief Title
Monopolar and Bipolar Current RFA Knife in POEM
Official Title
Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in POEM (Per-Oral Endoscopic Myotomy)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Motility Disorders
Keywords
Achalasia, Dysphagia, Per-Oral Endoscopic Myotomy, Bipolar electrocautery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups with patients randomized into receiving either the standard of care bipolar electrocautery tool or monopolar electrocautery tool.
Masking
Participant
Masking Description
Patient will not know which electrocautery tool will be used in their procedure.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monopolar Electrocautery tool
Arm Type
Active Comparator
Arm Description
Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure.
Arm Title
Bipolar Electrocautery tool
Arm Type
Experimental
Arm Description
Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.
Intervention Type
Procedure
Intervention Name(s)
Per-oral Endoscopic Myotomy
Other Intervention Name(s)
POEM
Intervention Description
Therapeutic endoscopy procedure by means of electrocautery surgical tools for treatment of various esophageal conditions such as achalasia or spastic esophageal disorders.
Intervention Type
Device
Intervention Name(s)
Speedboat (Bipolar electrocautery knife)
Other Intervention Name(s)
Speedboat Inject
Intervention Description
Use of Creo Medical's Speedboat RS2 knife and generator in performing the POEM procedure for patients presenting with an esophageal motility disorder.
Primary Outcome Measure Information:
Title
Change in pain score
Description
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.
Time Frame
Pre-procedure, 1-hour post procedure, 8-10 hours post procedure, and 24 hours post procedure.
Secondary Outcome Measure Information:
Title
Technical success rate of patients who completed POEM procedure with the bipolar knife.
Description
Completion of POEM procedure with the Speedboat-RS2 knife
Time Frame
Day 1
Title
Total procedure time (minutes)
Description
Includes time from incision, tunneling, dissection and closure.
Time Frame
Day 1
Title
Study knife removal during procedure
Description
Total number of times the Speedboat knife needed to be removed for another device during mucosal incision, submucosal dissection, or myotomy.
Time Frame
Day 1
Title
Hospital Length-of-stay
Description
Number of days patient remains in hospital following procedure
Time Frame
Up to 1 week
Title
Adverse events
Description
Collection of unanticipated medical occurrences within a 12 month time frame.
Time Frame
1 month, 3 months, 6 months, and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mercado
Phone
713-798-3606
Email
Michael.Mercado@bcm.edu
First Name & Middle Initial & Last Name & Degree
Salmaan Jawaid, MD
Phone
713-798-0950
Email
Salmaan.Jawaid@bcm.edu
First Name & Middle Initial & Last Name & Degree
Salmaan Jawaid, MD
First Name & Middle Initial & Last Name & Degree
Mohamed Othman, MD
Facility Name
Asian Institute of Gastroenterology (AIG) Hospitals
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B Rajeshwari, PharmD
Phone
040 6744 4222
Email
rajeshwaribaig@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohan Ramchandani, MD
Facility Name
Navarra Hospital Complex - Navarra Hospital
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheyla Montori Pina, PhD, MSc
Phone
+(34) 848 42 57 37
Email
sheyla.montori.pina@navarra.es
First Name & Middle Initial & Last Name & Degree
Eduardo Arbeniz Arbizu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.
Citations:
PubMed Identifier
23990482
Citation
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.
Results Reference
background
Citation
Saunders B P, Tsiamoulos Z P, Bourikas L et al.The
Results Reference
background
PubMed Identifier
32743048
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.
Results Reference
background

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Monopolar and Bipolar Current RFA Knife in POEM

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