TY - JOUR
T1 - 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
AU - van Munster, Sanne N.
AU - Pouw, Roos E.
AU - Sharma, Virender K.
AU - Meijer, Sybren L.
AU - Weusten, Bas L. A. M.
AU - Bergman, Jacques J. G. H. M.
N1 - Funding Information: This was an investigator-initiated study and was in part financially supported by Aqua Medical, Inc.; V.K. Sharma is a consultant, director, and equity holider for AquaMedical, Inc. B.L.A.M. Weusten has received financial support from Aqua Medical, Inc., Medtronic, and Pen-tax Medical for IRB-approved studies. J.J.G.H.M Bergman has received financial support from Aqua Medical, Inc., Medtronic, and Pentax Medical for IRB-approved studies. The remaining authors declare that they have no conflict of interest. Publisher Copyright: © 2021. Thieme. All rights reserved.
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85101333103&partnerID=8YFLogxK
U2 - https://doi.org/10.1055/a-1319-5550
DO - https://doi.org/10.1055/a-1319-5550
M3 - Article
C2 - 33225431
SN - 0013-726X
VL - 53
SP - 1162
EP - 1168
JO - Endoscopy
JF - Endoscopy
IS - 11
ER -