Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System (HALO)

January 9, 2014 updated by: Virendra Joshi, Ochsner Health System

Single Center Patient Registry Using Radio Frequency Ablation of Barrett's Esophagus Using HALO System

The purpose of this study is to provide a tool for physicians to compare outcome data related to the use of the HALO Ablation Systems. This study is a single-center patient registry which will contribute to a framework for treatment and follow-up of patients with Barrett's Esophagus.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Kenner, Louisiana, United States
        • Ochsner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients presenting with esophageal intestinal metaplasia (IM), including the pathological subclasses of non-dysplastic IM, low-grade dysplasia (LGD) and high-grade dysplasia (HGD)

Description

Inclusion Criteria:

  • candidate for ablation of Barrett's Esophagus with the HALO Ablation System (Prospective)
  • received an ablation with the HALO Ablation System to treat Barrett's Esophagus (Retrospective)
  • candidate agrees to proposed follow-up schedule of yearly surveillance following treatment
  • signs consent

Exclusion Criteria:

  • has not been diagnosed with Barrett's Esophagus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non-Dysplastic IM, LGD, HGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopic clearance rate for Barrett's Esophagus
Time Frame: Outcome measure is assessed at Month 12
Outcome measure is assessed at Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Histological clearance rate for intestinal metaplasia
Time Frame: Biopsy taken at 12 months
Biopsy taken at 12 months

Other Outcome Measures

Outcome Measure
Time Frame
Histological clearance rate for dysplasia
Time Frame: Biopsy taken at 12 months to determine effectiveness
Biopsy taken at 12 months to determine effectiveness

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Principal Investigator: Virendra Joshi, MD, Oshsner Clinic Foundation and Medical Center-Kenner

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Barrett's RFA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Barrett's Esophagus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe