Spots Global Cancer Trial Database for HALO Patient Registry: Ablation of Barrett's Esophagus

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Trial Identification

Brief Title: HALO Patient Registry: Ablation of Barrett's Esophagus

Official Title: HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry

Study ID: NCT00848237

Conditions

Barrett Esophagus

Interventions

Radiofrequency Ablation (HALO Ablation Systems)

Study Description

Brief Summary: The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems.

Detailed Description: Summary The HALO Patient Registry provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems. Protocol Design: This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms on-line. "Retrospective data collection" is defined as any data other than patient history collected prior to signing of the informed consent. A set of case report forms (CRFs) is provided along with this protocol to track outcomes. The CRFs may be completed and retained on site, but the site is recommended to utilize the internet-based data entry system.