HALO Patient Registry: Ablation of Barrett's Esophagus
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry|
- Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.
- Histological Clearance Rate for Intestinal Metaplasia (CE-IM) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
- Histological Clearance Rate for Dysplasia (CE-D) [ Time Frame: 1 year ] [ Designated as safety issue: No ]percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up
- Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up [ Time Frame: 1 year ] [ Designated as safety issue: No ]Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface
- Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month [ Time Frame: 12 month ] [ Designated as safety issue: No ]Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).
- Adverse Event Incidence [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]Adverse and Serious Adverse event with Definite device relationship
|Study Start Date:||July 2007|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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.
Summary The HALO Patient Registry 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.
This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms on-line. "Retrospective data collection" is defined as any data other than patient history collected prior to signing of the informed consent. A set of case report forms (CRFs) is provided along with this protocol to track outcomes. The CRFs may be completed and retained on site, but the site is recommended to utilize the internet-based data entry system.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848237
|United States, California|
|Gastrointestinal Associates and sites across the US|
|Knoxville and other US cities, California, United States, 27599-7080|
|Principal Investigator:||Nicholas J Shaheen, MD||University of North Carolina, Chapel Hill|