HALO Patient Registry: Ablation of Barrett's Esophagus, A Multi-Center Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,521
- 试验地点
- 2
- 主要终点
- Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnancy
- •Prior radiation therapy to the esophagus
- •Esophageal varices at risk for bleeding
- •Prior Heller Myotomy
结局指标
主要结局
Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
时间窗: 1 year
% 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)
时间窗: 1 year
Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
Histological Clearance Rate for Dysplasia (CE-D)
时间窗: 1 year
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
时间窗: 1 year
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
Adverse Event Incidence
时间窗: 12 month
Adverse and Serious Adverse event with Definite device relationship
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month
时间窗: 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).
次要结局
未报告次要终点