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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
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.
||Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
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)|
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.
|Ages Eligible for Study:||N/A|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Must be a candidate for ablation of Barrett's esophagus with the HALO Ablation
- Must agree to the proposed follow-up schedule and provide informed consent for
- Prior radiation therapy to the esophagus
- Esophageal varices at risk for bleeding
- Prior Heller Myotomy
- Investigator: David S Utley, MD - Study Director - B?RRX Medical, Inc.