HALO Patient Registry: Ablation of Barrett's Esophagus

NCT00848237 | Completed Results

• 1 other identifier: B-500
• Study Type: interventional
• Target: 5,521
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus

Keywords

Barrett's Esophagus; Dysplasia; Intestinal Metaplasia

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• Adverse Event Incidence

  Adverse and Serious Adverse event with Definite device relationship

  12 month

Study Arms (1)

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)

Interventions

Radiofrequency Ablation (HALO Ablation Systems) DEVICE

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.

Also known as: HALO 90, HALO 360

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Prior radiation therapy to the esophagus
• Esophageal varices at risk for bleeding
• Prior Heller Myotomy

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Gastrointestinal Associates and sites across the US

Knoxville and Other US Cities, California, 27599-7080, United States

Location

Related 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 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.

  PMID: 22965650 RESULT

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Endoscopic clearance rate for Barrett's esophagus-Percentage of patients with no endoscopically visible Barrett's esophagus at 1 year follow-up: This endpoint is a visual and not reliable or accurate.

Results Point of Contact

• Title: Nicholas Shaheen
• Organization: University of north Carolina

nshaheen@med.unc.edu

(919) 966-7047

Study Officials

• Nicholas J Shaheen, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: February 20, 2009
• Study Start: July 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 5, 2016
• Results First Posted: February 5, 2016

Record last verified: 2016-01

Locations

US (1)