HALO Patient Registry: Ablation of Barrett's Esophagus

Medtronic

Status: Completed

Conditions: Barrett Esophagus

Treatments: Device: Radiofrequency Ablation (HALO Ablation Systems)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848237

B-500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,521 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be a candidate for ablation of Barrett's esophagus with the HALO Ablation System.
• Must agree to the proposed follow-up schedule and provide informed consent for participation.

Exclusion criteria

• Pregnancy
• Prior radiation therapy to the esophagus
• Esophageal varices at risk for bleeding
• Prior Heller Myotomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,521 participants in 1 patient group

Treatment

Experimental group

Description:

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Treatment:

Device: Radiofrequency Ablation (HALO Ablation Systems)