Clinical Trial: HALO Patient Registry: Ablation of Barrett's Esophagus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Medtronic - MITG

Current Primary Outcome:

  • Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up [ Time Frame: 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) [ Time Frame: 1 year ]
    Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
  • Histological Clearance Rate for Dysplasia (CE-D) [ Time Frame: 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 [ Time Frame: 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
  • Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month [ Time Frame: 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 a

    Original Primary Outcome:

    • Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up [ Time Frame: 1 year ]
    • Histological clearance rate for intestinal metaplasia--Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up [ Time Frame: 1 year ]
    • Histological clearance rate for dysplasia--percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up [ Time Frame: 1 year ]
    • Sub-squamous intestinal metaplasia--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 [ Time Frame: 1 year ]
    • Patient quality of life questionnaire results comparing baseline versus 12 month [ Time Frame: 12 month ]
    • Adverse Event Incidence [ Time Frame: 12 month ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Medtronic - MITG

    Dates:
    Date Received: December 20, 2007
    Date Started: July 2007
    Date Completion:
    Last Updated: January 5, 2016
    Last Verified: January 2016