Vapor ablation can effectively and safely eradicate short BE segments
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Health condition
Barrett esophagus, Barrett neoplasia
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
BE surface regression after 8-12 weeks FU, incidence of adverse events
Secondary outcome
Feasibility to ablate the entire area as intended, duration of ablation, device malfunction, pain scores
Background summary
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.
Study objective
Vapor ablation can effectively and safely eradicate short BE segments
Study design
Baseline, 6-8 weeks FU
Intervention
Vapor ablation
Age
Inclusion criteria
Flat Barrett's esophagus (BE) with an indication for ablation therapy ( either flat confirmed LGD, flat HGD, or residual flat BE after endoscopic resection of early, non-flat BE neoplasia)
Exclusion criteria
Presence of visible lesions, history of advanced BE neoplasia (either sm2+, LVI+ or G3+).
Design
Recruitment
IPD sharing statement
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8369 |
| CCMO | NL73052.018.20 |
| OMON | NL-OMON55125 |