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HALO Patient Registry: Ablation of Barrett's Esophagus

Primary Purpose

Barrett Esophagus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency Ablation (HALO Ablation Systems)
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett Esophagus focused on measuring Barrett's Esophagus, Dysplasia, Intestinal Metaplasia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gastrointestinal Associates and sites across the US

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Outcomes

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
% 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.
Histological Clearance Rate for Intestinal Metaplasia (CE-IM)
Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
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
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
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).
Adverse Event Incidence
Adverse and Serious Adverse event with Definite device relationship

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
January 5, 2016
Sponsor
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT00848237
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
Keywords
Barrett's Esophagus, Dysplasia, Intestinal Metaplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Intervention Type
Device
Intervention Name(s)
Radiofrequency Ablation (HALO Ablation Systems)
Other Intervention Name(s)
HALO 90, HALO 360
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
Description
% 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.
Time Frame
1 year
Title
Histological Clearance Rate for Intestinal Metaplasia (CE-IM)
Description
Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
Time Frame
1 year
Title
Histological Clearance Rate for Dysplasia (CE-D)
Description
percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up
Time Frame
1 year
Title
Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up
Description
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
Title
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month
Description
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).
Time Frame
12 month
Title
Adverse Event Incidence
Description
Adverse and Serious Adverse event with Definite device relationship
Time Frame
12 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas J Shaheen, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrointestinal Associates and sites across the US
City
Knoxville and other US cities
State/Province
California
ZIP/Postal Code
27599-7080
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22965650
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.
Results Reference
result

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HALO Patient Registry: Ablation of Barrett's Esophagus

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