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Completed

NCT Number: NCT00848237

HALO Patient Registry: Ablation of Barrett's Esophagus

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastrointestinal Associates and sites across the US

Knoxville and Other US Cities, California, 27599-7080, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency Ablation (HALO Ablation Systems)

Device

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.

Other names: HALO 90, HALO 360

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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 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).

  6. Adverse Event Incidence

    Time frame: 12 month

    Adverse and Serious Adverse event with Definite device relationship

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2009
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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