Study on the Safety, Tolerability and Efficacy of the Aqua Medical focal vapor ablation system, for the eradication of Barrett's Esophagus - part 2
Not Applicable
Recruiting
- Conditions
- <p>Barrett esophagus, Barrett neoplasia</p>10017991
- Registration Number
- NL-OMON20279
- Lead Sponsor
- Aqua Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 19
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+).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>BE surface regression after 8-12 weeks FU, incidence of adverse events</p><br>
- Secondary Outcome Measures
Name Time Method <p>Feasibility to ablate the entire area as intended, duration of ablation, device malfunction, pain scores</p><br>