HALO Patient Registry: Ablation of Barrett's Esophagus

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Protocol Design: 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.

Official Title
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HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Device: Radiofrequency Ablation (HALO Ablation Systems)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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)<br>* 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.<br>* Other names: HALO 360;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up | % 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. | 1 year | 
| Histological Clearance Rate for Intestinal Metaplasia (CE-IM) | Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up | 1 year | 
| Histological Clearance Rate for Dysplasia (CE-D) | percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up | 1 year | 
| Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up | 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 | 1 year | 
| Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month | 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). | 12 month | 
| Adverse Event Incidence | Adverse and Serious Adverse event with Definite device relationship | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's Esophagus, Dysplasia, Intestinal Metaplasia