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

Phase 2

Completed

• Conditions: Dysplasia in Barrett's; precancerous esophageal mucosa; 10017990

• Registration Number: NL-OMON35335
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

- 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.
- One or more BE islands with a minimum size of 5-mm.
- Written informed consent

Exclusion Criteria

Patients with endoscopically active inflammation in the treatment zone.
- Esophageal stenosis preventing advancement of the endoscope with the HALO90 catheter.
- Patients unable to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcome parameters will be assessed after a single HALO90 treatment session:<br /><br>- Rate of complete removal of BE islets<br /><br>- Percentage of endoscopically visual surface regression of BE epithelium after<br /><br>2 months as scored by two endoscopists blinded to the treatment regimen</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>non</p><br>