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.
Endoscopy
; 53(11): 1162-1168, 2021 11.
Article
in En
| MEDLINE
| ID: mdl-33225431
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 100â°C using an RF electrode located in the catheter tip.âWe 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 55â% (IQR 33â-â74) and 98â% (56â-â99) 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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Barrett Esophagus
/
Esophageal Neoplasms
/
Catheter Ablation
Limits:
Animals
/
Humans
Language:
En
Journal:
Endoscopy
Year:
2021
Document type:
Article
Affiliation country:
Netherlands