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Clinical Trials/NL-OMON35335
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

Academisch Medisch Centrum0 sites64 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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