HALO Patient Registry: Ablation of Barrett's Esophagus - Full Text View

Sponsored by:	BÂRRX Medical, Inc.
Information provided by:	BÂRRX Medical, Inc.
ClinicalTrials.gov 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.

Condition	Intervention
Barrett Esophagus	Device: Radiofrequency Ablation (HALO Ablation Systems)

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry

Resource links provided by NLM:

MedlinePlus related topics: Ataxia Telangiectasia

U.S. FDA Resources

Further study details as provided by BÂRRX Medical, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Patient quality of life questionnaire results comparing baseline versus 12 month [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Adverse event incidence [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3000
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.	Device: Radiofrequency Ablation (HALO Ablation Systems) 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.

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.

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848237

Contacts

Contact: Shirin R Hasan	408-328-7338	shasan@barrx.com
Contact: David S Utley, MD	408-328-7309	dutley@barrx.com

Locations

United States, Tennessee
Gastrointestinal Associates	Recruiting
Knoxville, Tennessee, United States, 37909

Sponsors and Collaborators

BÂRRX Medical, Inc.

Investigators

Study Director:

David S Utley, MD

BÂRRX Medical, Inc.

More Information

No publications provided

Responsible Party:	Barrx Medical Inc ( David S. Utley, MD )
Study ID Numbers:	B-500
Study First Received:	December 20, 2007
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00848237 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by BÂRRX Medical, Inc.:

Barrett's Esophagus
Dysplasia
Intestinal Metaplasia

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Abnormalities
Proton Pump Inhibitors
Esophageal Disorder
Barrett Syndrome

Gastrointestinal Diseases
Metaplasia
Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities

Additional relevant MeSH terms:

Digestive System Diseases
Digestive System Abnormalities
Gastrointestinal Diseases
Barrett Esophagus
Esophageal Diseases

ClinicalTrials.gov processed this record on August 30, 2009