Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
研究概览
简要总结
The goal of this research is to follow Barrett's Esophagus participants for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.
详细描述
The progression of Barrett's Esophagus will be studied over time using tethered capsule endomicroscopy imaging and will be performed at 5 different clinical centers in the US, namely: Massachusetts General Hospital (MGH),(MA), Mayo Clinic Jacksonville (FL), Mayo Clinic Rochester (MN), Columbia University Medical Center (NY), Kansas City VA Medical Center (MO). MGH will be the coordinating center of this multicenter study. Dr G. Tearney will serve as study Sponsor Investigator.
The purpose of this study is to determine the natural history of Barrett's Esophagus using TCE in participants diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants over the age of 18
- •Participants who are capable of giving informed consent
- •Participants with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy
- •Participants who had or will have a standard of care EGD within 15 months, exceptions to this can be submitted to the coordinating center (MGH) for approval
排除标准
- •Participants with prior endoscopic ablation or resection treatment of BE at enrollment visit
- •Participants with esophageal fistula and/or esophageal strictures
- •Participants with the inability to swallow capsules
- •Concomitant chemotherapy treatment
- •Self reported pregnancy
结局指标
主要结局
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
时间窗: 4 years
We will be measuring the size of the area affected by Barrett's.
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
时间窗: 4 years
We will be measuring the size of the area affected by Barrett's.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Professor of Pathology, HMS
Massachusetts General Hospital