Self-sizing Radiofrequency Ablation balloonfor eradication of Barrett's esophagus: arandomized trial comparing three differenttreatment regimens
Completed
- Conditions
- Barrett's esophagus, Barrett's neoplasia, Barrett's dysplasia, Radiofrequency ablation, Intestinal metaplasia
- Registration Number
- NL-OMON24632
- Lead Sponsor
- KU Gasthuisberg Leuven, Belgium
- Brief Summary
In preparation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
Inclusion Criteria
1. Patients aged 18-85 years, with biopsy proven LGD, HGD or EC in a BE after local expert
pathology review.
Exclusion Criteria
1. Patients with a BE segment < 2cm or >15 cm prior to ER.
2. Any prior endoscopic ablation treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome:<br /><br>Percentage of endoscopically visual surface regression of BE epithelium at 3 months, as scored<br>by two independent endoscopists blinded to the treatment regimen.
- Secondary Outcome Measures
Name Time Method 1. Adverse events<br /><br>2. Patient’s discomfort after RFA treatment<br /><br>3. Procedure time