NL-OMON35335
Completed
Phase 2
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 - Optimization of HALO90 ablation of Barrett's mucosa
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Dysplasia in Barrett's
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 64
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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