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, Roos E. Pouw, Virender K. Sharma, Sybren L. Meijer, Bas L. A. M. Weusten, Jacques J. G. H. M. Bergman*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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.
Original languageEnglish
JournalEndoscopy
Early online date2021
DOIs
Publication statusE-pub ahead of print - 2021

Cite this