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HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry
This study is currently Recruiting
March 2011 By B?RRX Medical, Inc.
First Recieved on December 20, 2007
Last Updated on March 18, 2011
Purpose
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.
| Study Type: |
Interventional |
| Study Design: |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Resources/Links provided by NLM:
| Estimated Enrollment: |
10000 |
| Study Start Date: |
July 2007 |
| Estimated Primary Completion Date: |
July 2014 |
| Arms |
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. |
| Assigned Interventions |
Device:Radiofrequency Ablation (HALO Ablation Systems)
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. |
Eligibility
| Ages Eligible for Study: | N/A |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Investigators
- Investigator: David S Utley, MD - Study Director - B?RRX Medical, Inc.
