Improving practicality of radiofrequency ablation for eradication of Barrett's mucosa: A randomized trial comparing two different treatment regimens for focal ablation using the HALO90 System.

Recruiting

Conditions: Barrett's esophagus
early Barrett's neoplasia
Barrett's dysplasia
Intestinal metaplasia
Intraepithelial neoplasia
radiofrequencty ablation

Registration Number: NL-OMON24115

Lead Sponsor: AMC Amsterdam

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 46

Inclusion Criteria

1. Scheduled HALO90 ablation for BE (with or without neoplasia) after prior circumferential ablation using the HALO360 System for BE with flat low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or for BE (with or without neoplasia) after prior endoscopic resection (ER) for lesions containing HGD or and early cancer;

2. One or more BE islands with a minimum size of 5-mm;

Exclusion Criteria

1. Patients with endoscopically active inflammation in the treatment zone;

2. Esophageal stenosis preventing advancement of the endoscope with the HALO90 catheter.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of complete removal of BE islets (completely remove yes/no), as scored by the endoscopist (blinded for the allocation of the islands but nor the location of the islands that were randomized and treated) after 2 months as scored during the endoscopy using a standard case record form.

Secondary Outcome Measures

Name	Time	Method
1. Percentage of endoscopically visual surface regression of BE epithelium after 2 months as scored by the endoscopist blinded to the treatment regimen during the endoscopy using a standard case record form, by a study monitor;<br /><br>2. Number of introductions of the ablation device and endoscope as scored during the endoscopy using a standard case record form by a study monitor;<br /><br>3. Complications as assessed by a telephone interview one or two days after the procedure and by registration using a standard case record form.