The STEAM-BE study
Recruiting
- Conditions
- Barrett's esophagus
- Registration Number
- NL-OMON28412
- Lead Sponsor
- Academic Medical Center, Amsterdam (AMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
Inclusion:
a.Subject is between 22 ¨C 85 years of age.
Exclusion Criteria
Exclusion:
a.Subject has any condition that in the opinion of the PI preclude enrollment into the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety will be assessed by the incidence and severity of any complications that are associated with the vapor ablation throughout the follow-up period. <br /><br>The primary efficacy endpoint is the complete regression of intestinal metaplasia with each vapor ablation dose at 6-8 weeks follow-up as ascertained by endoscopic visualization and histopathologic evaluation.
- Secondary Outcome Measures
Name Time Method Feasibility, tolerability, dose-effects