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DOI: 10.1055/a-1319-5550
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
Trial Registration: Netherlands National Trial Register (www.trialregister.nl) Registration number (trial ID): NL7270 Type of study: Prospective feasibility study![](https://www.thieme-connect.de/media/endoscopy/202111/lookinside/thumbnails/19779_10-1055-a-1319-5550-1.jpg)
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.
Publikationsverlauf
Eingereicht: 31. Juli 2020
Eingereicht: 20. November 2020
Angenommen: 20. November 2020
Accepted Manuscript online:
20. November 2020
Artikel online veröffentlicht:
18. Februar 2021
© 2020. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
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