HALO Patient Registry: Ablation of Barrett's Esophagus

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848237
• Other study ID #: B-500
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: January 5, 2016
• Start date: July 2007
• Est. completion date: July 2014

Study information

• Verified date: January 2016
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5521
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

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.

Locations

Country	Name	City	State
United States	Gastrointestinal Associates and sites across the US	Knoxville and other US cities	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ablati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up	% 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.	1 year	No
Primary	Histological Clearance Rate for Intestinal Metaplasia (CE-IM)	Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up	1 year	No
Primary	Histological Clearance Rate for Dysplasia (CE-D)	percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up	1 year	No
Primary	Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up	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	1 year	No
Primary	Patient Quality of Life Questionnaire Results: Change From Baseline to 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).	12 month	No
Primary	Adverse Event Incidence	Adverse and Serious Adverse event with Definite device relationship	12 month	Yes