Novel cryoballoon 180° ablation system for treatment of Barrett's esophagus-related neoplasia: a first-in-human study.
Endoscopy
; 54(1): 64-70, 2022 01.
Article
em En
| MEDLINE
| ID: mdl-33662991
ABSTRACT
BACKGROUND:
The novel 180° cryoballoon (CbAS180) enables semicircumferential treatment over a length of 3âcm per application. This first-in-human study evaluates its feasibility, efficacy, and safety for the treatment of Barrett's esophagus (BE) neoplasia.METHODS:
This multicenter study consisted of dose-finding and extension phases. Dose-finding started with the lowest dose possible (1.0âmm/s). For each dose, six patients were treated circumferentially over a 3-cm length. The dose was increased until the median BE regression wasâ≥â60â% without serious adverse events (SAEs). In the extension phase, the dose was confirmed in 19 new patients. The outcomes were technical success, BE regression after one treatment, and SAEs.RESULTS:
25 patients (median Prague C0M3) were included (6 dose-finding/19 extension). In two patients, the CbAS180 could not be applied because of unstable balloon positioning. The technical success rate was 96â% (22â/23). In the six dose-finding patients, the starting dose resulted in median BE regression of 94â% (95â% confidence interval [CI] 60â%-97â%) without SAEs and was thus considered effective. Overall median BE regression was 80â% (95â%CI 60â%-90â%).CONCLUSION:
Single-session CbAS180 seems feasible, safe, and effective, and is a promising technique for the treatment of patients with BE neoplasia.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article