Barrett's esophagus precancerious condition
Conditions
Interventions
Patients, who are randomized for radiofrequency ablation will be treated for
low-grade dysplasia in Barrett's esophagus with radiofrequency ablation.
Sponsors
BARRx Medical Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Low-grade dysplasia in Barrett's slokdarm
Exclusion criteria
Exclusion criteria: Patients with a Barrett's segment of >12cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of high-grade dysplasia and early cancer during two year follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of total histological eradication of LGD 2. Rate of total endoscopic eradication of Barrett*s mucosa 3. Rate of total histological eradication of Barrett*s mucosa 4. Number of procedures and costs 5. Acute and late complications of RFA 6. Percentage of surface regression of Barrett*s epithelium | — |
Countries
Netherlands
Outcome results
None listed