Studie naar de veiligheid, tolerabiliteit and effectiviteit van het Aqua Medical Focale Stoom ablatie systeem voor de ablatie van Barrett Slokdarm - deel 2

We will assess the feasibility, safety and efficacy of Aqua Medical focal Vapor ablation for the treatment of short segment Barrett's esophagus. Vapor ablation is a new method for eradication of Barrett's esophagus and uses the energy of heated, vaporized water to ablate the Barrett's mucosa and to facilitatie regrowth of normal squamous epithelium under acid suppression. Different catheters are available and in the current study we use a focal hood-based catheter and a standardized dose of 3 seconds will be used. In total, 19 patients will be enrolled and treated with side-by-side focal applications of vapor ablation, to assess the feasibility, safety and efficacy of treating short segment Barrett's esophagus with Focal Vapor ablation. The study consists of 3 phases: in phase I, 3 patients will be included and the catheter will be introduced to assess whether all areas could be targeted in a resonable timeframe as compared to focal RFA, no treatment will be performed in this phase. If this phase will be successfully completed, we will continue to phase II. In Phase II, 6 patients will be included and treated circumferentially at the GEJ. If we will be able to ablate the entire GEJ in a reasonable timeframe and in absence of related complications, we will continue to Phase III. In this final phase, we will include 10 patients with short segment BE to treat the entire BE segment. A follow-up endoscopy will be performed after 8-12 weeks to assess the BE surface regression and for histologic sampling.

Vapor ablation can effectively and safely eradicate short BE segments

Baseline, 6-8 weeks FU

Vapor ablation