Barrett's Esophagus Clinical Trial
— HALOOfficial title:
Single Center Patient Registry Using Radio Frequency Ablation of Barrett's Esophagus Using HALO System
The purpose of this study is to provide a tool for physicians to compare outcome data related to the use of the HALO Ablation Systems. This study is a single-center patient registry which will contribute to a framework for treatment and follow-up of patients with Barrett's Esophagus.
Status | Not yet recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - candidate for ablation of Barrett's Esophagus with the HALO Ablation System (Prospective) - received an ablation with the HALO Ablation System to treat Barrett's Esophagus (Retrospective) - candidate agrees to proposed follow-up schedule of yearly surveillance following treatment - signs consent Exclusion Criteria: - has not been diagnosed with Barrett's Esophagus |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Ochsner Medical Center | Kenner | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Ochsner Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Histological clearance rate for dysplasia | Biopsy taken at 12 months to determine effectiveness | No | |
Primary | Endoscopic clearance rate for Barrett's Esophagus | Outcome measure is assessed at Month 12 | No | |
Secondary | Histological clearance rate for intestinal metaplasia | Biopsy taken at 12 months | No |
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