NCT00848237

HALO Patient Registry: Ablation of Barrett's Esophagus

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,521 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation (HALO Ablation Systems)	Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Timeline

• Start date: 2007-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2009-02-20
• Last updated: 2016-02-05
• Results posted: 2016-02-05

Locations

1 site across 1 country: United States