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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05272046
Other study ID # H-50587
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 22, 2022
Est. completion date April 1, 2025

Study information

Verified date March 2024
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date April 1, 2025
Est. primary completion date February 19, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
India Asian Institute of Gastroenterology (AIG) Hospitals Hyderabad
Spain Navarra Hospital Complex - Navarra Hospital Pamplona
United States Baylor College of Medicine Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Countries where clinical trial is conducted

United States,  India,  Spain, 

References & Publications (3)

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. — View 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. — View Citation

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

Outcome

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