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Endoscopy 2021; 53(11): 1162-1168
DOI: 10.1055/a-1319-5550
Innovations and brief communications

Radiofrequency vapor ablation for Barrett’s esophagus: feasibility, safety and proof of concept in a stepwise study with in vitro, animal, and the first in-human application

Sanne N. van Munster
1   Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands
2   Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands
,
Roos E. Pouw
1   Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands
,
Virender K. Sharma
3   Arizona Centers for Digestive Health, Scottsdale, Arizona, USA
,
Sybren L. Meijer
4   Department of Pathology, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands
,
Bas L. A. M. Weusten
1   Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands
5   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
,
Jacques J. G. H. M. Bergman
2   Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands
› Author AffiliationsTrial Registration: Netherlands National Trial Register (www.trialregister.nl) Registration number (trial ID): NL7270 Type of study: Prospective feasibility study
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Abstract

Introduction The Radiofrequency Vapor Ablation (RFVA) System (AquaMedical, Inc., Santa Ana, CA) is a novel ablation system for eradication of Barrett’s esophagus, that generates vapor at 100 °C using an RF electrode located in the catheter tip. We performed in-vitro dosimetry studies and the first in-human feasibility study.

Methods The system includes an RFVA generator with syringe pump and a through-the-scope-catheter. The RFVA system was tested in-vitro (lean-beef and porcine study) and ablation depth was compared to focal RFA. Two doses were selected for further in-vivo testing in dysplatic BE patients. Repeat endoscopy with histology was performed after 8 weeks to assess squamous conversion.

Results In porcine, RFVA 3-seconds was comparable to RFA, whereas RFVA 5-seconds produced slightly deeper ablation. We selected a conservative 1-second and 3-seconds for human study. Fifty-three ablations were successfully applied in 15 patients with no adverse events. Follow-up endoscopy showed a median squamous conversion of 55 % (IQR 33 – 74) and 98 % (56 – 99) for 1 and 3-seconds, respectively.

Conclusions In this 3-phase study with lean-beef, porcine and the first in-human application, the RFVA system was feasible for esophageal ablation and successfully and safely converted targeted BE areas into squamous epithelium.

Appendix 1s, 2s, Table 1s, 2s, Fig. 1s–3s



Publication History

Received: 31 July 2020
Received: 20 November 2020

Accepted: 20 November 2020

Accepted Manuscript online:
20 November 2020

Article published online:
18 February 2021

© 2020. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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