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

This study is currently Recruiting

March 2011 By B?RRX Medical, Inc.

First Recieved on December 20, 2007

Last Updated on March 18, 2011

Sponsor: B?RRX Medical, Inc.
Collaborators:
Information provided by: B?RRX Medical, Inc.
Identifier: NCT00848237

Purpose

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.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:N/A
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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

Investigators

  • Investigator: David S Utley, MD - Study Director - B?RRX Medical, Inc.

Locations

  • Gastrointestinal Associates and sites across the US

    Knoxville and other US cities, California United States

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