Clinical trial NCT00848237: HALO Patient Registry: Ablation of Barrett's Esophagus
Official title: HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Keywords: Barrett's Esophagus
Dysplasia
Intestinal Metaplasia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 5521
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
timeFrame: 1 year
measure: Histological Clearance Rate for Intestinal Metaplasia (CE-IM)
timeFrame: 1 year
measure: Histological Clearance Rate for Dysplasia (CE-D)
timeFrame: 1 year
measure: Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up
timeFrame: 1 year
measure: Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month
timeFrame: 12 month
measure: Adverse Event Incidence
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville and other US cities
country: United States
facility: Gastrointestinal Associates and sites across the US
state: California
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Nicholas J Shaheen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shaheen NJ, Kim HP, Bulsiewicz WJ, Lyday WD, Triadafilopoulos G, Wolfsen HC, Komanduri S, Chmielewski GW, Ertan A, Corbett FS, Camara DS, Rothstein RI, Overholt BF. Prior fundoplication does not improve safety or efficacy outcomes of radiofrequency ablation: results from the U.S. RFA Registry. J Gastrointest Surg. 2013 Jan;17(1):21-8; discussion p.28-9. doi: 10.1007/s11605-012-2001-8. Epub 2012 Sep 11.