Pilot Study for Imaging of the Esophagus Using an OFDI Capsule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
研究概览
简要总结
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
详细描述
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.
As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A previous diagnosis of Barrett's Esophagus
- •OR a previous diagnosis of EoE
- •OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
- •Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
- •Subject must be able to give informed consent
排除标准
- •Subjects with known esophageal strictures, intestinal strictures or dysphagia
- •OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
研究组 & 干预措施
OFDI Capsule Imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
干预措施: OFDI Capsule (Device)
结局指标
主要结局
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
时间窗: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Number of subjects from whom the quality OFDI imaging was obtained
次要结局
未报告次要终点
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital