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NCT02033070 Clinical Trial

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

Barrett's Esophagus Clinical Trial

— HALO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02033070
Other study ID # Barrett's RFA
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 8, 2014
Last updated January 9, 2014
Start date November 2013

Study information
Verified date January 2014
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Ochsner Medical Center Kenner Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Histological clearance rate for dysplasia Biopsy taken at 12 months to determine effectiveness No
Primary Endoscopic clearance rate for Barrett's Esophagus Outcome measure is assessed at Month 12 No
Secondary Histological clearance rate for intestinal metaplasia Biopsy taken at 12 months No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02864043 - Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System N/A
Recruiting NCT02018367 - Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma Phase 2
Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT01976351 - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus N/A
Terminated NCT00526786 - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus Phase 4
Completed NCT01401699 - Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction N/A
Completed NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy N/A
Suspended NCT01580631 - Narrow Band Imaging Project on Barrett's Esophagus
Completed NCT01439633 - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus N/A
Completed NCT02879721 - Expression and Function of the Renin-Angiotensin System in the Esophagus Phase 0
Completed NCT01439594 - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation N/A
Completed NCT01281618 - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus N/A
Completed NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus N/A
Completed NCT00588575 - Ramanspectroscopy in Barrett's Esophagus
Recruiting NCT00288119 - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed NCT03813381 - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO). N/A
Completed NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition N/A
Completed NCT01961778 - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma N/A
Completed NCT01733147 - Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids Phase 4