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CC BY-NC-ND 4.0 · Endosc Int Open 2023; 11(08): E743-E751
DOI: 10.1055/a-2085-3757
Original article

Settings of a novel electrosurgical generator to enable efficient and safe submucosal endoscopic procedures

Salmaan Jawaid
1   Gastroenterology, Baylor College of Medicine, Houston, United States (Ringgold ID: RIN3989)
,
Tara Keihanian
2   Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, United States (Ringgold ID: RIN3989)
,
Mai Khalaf
2   Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, United States (Ringgold ID: RIN3989)
,
Margarita Riojas-Barrett
2   Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, United States (Ringgold ID: RIN3989)
,
Wesam Abdeljaber
2   Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, United States (Ringgold ID: RIN3989)
,
Michael Mercado 
1   Gastroenterology, Baylor College of Medicine, Houston, United States (Ringgold ID: RIN3989)
,
Noor Zabad 
2   Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, United States (Ringgold ID: RIN3989)
,
Mohamed O. Othman 
2   Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, United States (Ringgold ID: RIN3989)
› Author AffiliationsSupported by: ConMed 2233368516

TRIAL REGISTRATION: Registration number (trial ID): NCT04752670, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective
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Abstract

Background and study aims A novel electrosurgical generator unit (ESU), ConMed Beamer, was recently introduced to facilitate endoscopic submucosal dissection (ESD) by employing Automatic Cutting Effect (ACE) technology. Its use in submucosal endoscopy has yet to be investigated. The aim of this study was to evaluate the feasibility and safety of performing ESD and peroral endoscopic myotomy (POEM) using novel settings generated with ConMed Beamer ESU.

Patients and methods This was a single-center prospective study of 59 consecutive patients undergoing ESD/POEM at a tertiary referral center. ESU settings were initially generated by testing in live animal models prior to first in-human study. The primary outcome was technical success. Secondary outcomes were procedure times, rate of en bloc/R0 resection, and rate of adverse events (AEs).

Results A total of 44 patients (50 polyps) and 15 patients underwent ESD and POEM, respectively. En bloc resection, R0 resection, and curative resection rates were 90%, 77.1%, and 70.8%, respectively. Mean maximal length of the lesion was 3.07 cm ± 1.43 with an average dissection speed of 14.2 cm2/hr ± 11.1. Technical success was achieved in 100% of POEM patients. Mean time (minutes) to complete the POEM procedure was 50.1 min ± 12.4. Two major AEs occurred among all patients (3.4%). All intraprocedural bleeding events were controlled using the ConMed Beamer ESU.

Conclusions ConMed Beamer ESU settings generated from this study were proven safe and effective in a prospective cohort of patients who underwent submucosal endoscopic procedures. This novel ESU can be added to the armamentarium of ESD capable generators.



Publication History

Received: 23 January 2023

Accepted after revision: 18 April 2023

Accepted Manuscript online:
03 May 2023

Article published online:
16 August 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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