HALO Patient Registry: Ablation of Barrett's Esophagus

Not Applicable

Completed

Conditions: Barrett Esophagus

Interventions: Device: Radiofrequency Ablation (HALO Ablation Systems)

Registration Number: NCT00848237

Lead Sponsor: Medtronic - MITG

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5521

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Radiofrequency Ablation (HALO Ablation Systems)	All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Primary Outcome Measures

Name	Time	Method
Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up	1 year	% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.
Histological Clearance Rate for Intestinal Metaplasia (CE-IM)	1 year	Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
Histological Clearance Rate for Dysplasia (CE-D)	1 year	percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up
Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up	1 year	Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface
Adverse Event Incidence	12 month	Adverse and Serious Adverse event with Definite device relationship
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month	12 month	Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).