Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
研究概览
简要总结
The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).
详细描述
36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated.
The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.
As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).
- •AND Subject must be able to give informed consent.
- •AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.
排除标准
- •Subjects with any history of or known upper gastrointestinal strictures
- •OR Subjects with a history of Crohn's disease,
- •OR Subjects with difficulty swallow
研究组 & 干预措施
MGH SECM Imaging Capsule
Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.
干预措施: MGH SECM Imaging Capsule (Device)
结局指标
主要结局
Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
时间窗: 20 minute visit (5-7 minute imaging)
The number of subjects from whom successful SECM imaging was obtained
次要结局
未报告次要终点
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital