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

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ClinicalTrials.gov Identifier: NCT02033070
Recruitment Status : Unknown
Verified January 2014 by Virendra Joshi, Ochsner Health System.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Virendra Joshi, Ochsner Health System

Brief Summary:
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.

Condition or disease
Barrett's Esophagus

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Study Type : Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Single Center Patient Registry Using Radio Frequency Ablation of Barrett's Esophagus Using HALO System
Study Start Date : November 2013
Estimated Primary Completion Date : November 2015

Group/Cohort
Non-Dysplastic IM, LGD, HGD



Primary Outcome Measures :
  1. Endoscopic clearance rate for Barrett's Esophagus [ Time Frame: Outcome measure is assessed at Month 12 ]

Secondary Outcome Measures :
  1. Histological clearance rate for intestinal metaplasia [ Time Frame: Biopsy taken at 12 months ]

Other Outcome Measures:
  1. Histological clearance rate for dysplasia [ Time Frame: Biopsy taken at 12 months to determine effectiveness ]

Biospecimen Retention:   Samples Without DNA
Serum from Biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033070


Locations
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United States, Louisiana
Ochsner Medical Center Active, not recruiting
Kenner, Louisiana, United States
Sponsors and Collaborators
Ochsner Health System
Investigators
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Principal Investigator: Virendra Joshi, MD Oshsner Clinic Foundation and Medical Center-Kenner

Additional Information:

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Responsible Party: Virendra Joshi, Virendra Joshi, MD, Ochsner Health System
ClinicalTrials.gov Identifier: NCT02033070     History of Changes
Other Study ID Numbers: Barrett's RFA
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Virendra Joshi, Ochsner Health System:
RFA
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases