A multi-centre randomized trial comparing Radiofrequency Ablation with Radical Endoscopic Resection for treatment of Barrett's Esophagus with High-grade Dysplasia or Early Cancer.

Recruiting

• Conditions: Barrett esophagus; high-grade dysplasia; high-grade intraepithelial neoplasia; intramucosal cancer; Barrett neoplasia; intestinal metaplasia.Barrett slokdarm; hooggradige dysplasie; hoogradige intraepitheliale neoplasie; Barrett neoplasie; intestinale metaplasie.

• Registration Number: NL-OMON21764
• Lead Sponsor: BÂRRX Medical Inc.540 Oakmead ParkwaySunnyvale, CA 94085

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Patients with biopsy proven HGD or EC in a Barrett's esophagus in at least 2 endoscopic procedures prior to randomization, of which the last was within 3 months of randomization.

2. Age between 18 and 85 years.

Exclusion Criteria

1. Length of Barrett's esophagus > 5 cms.

2. Deep submucosal infiltration („dT1sm2) in the endoscopic resection specimen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Rate of total histological eradication of HGD and/or EC <br /><br>2. Rate of total endoscopic eradication of Barrett's mucosa<br /><br>3. Rate of total histological eradication of Barrett's mucosa<br /><br>

Secondary Outcome Measures

Name	Time	Method
1. Acute and late complications of RER/RFA<br /><br>2. Percentage of surface regression of Barrett's epithelium<br /><br>3. Costs of materials and procedures<br>