Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Assessment of quality and performance of Compact Imaging System (CIS)
研究概览
简要总结
The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
详细描述
Ten healthy participants and ten participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.
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 peristalsis.
Images of the esophagus will be 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
- •Participants 18 years and older with a previous diagnosis of GERD
- •Participants 14 years and older with a previous diagnosis of EoE (not an inclusion criteria for healthy volunteers)
- •Health participants over the age of 18 but less than 85 years of age
- •Participants must be able to give informed consent
- •Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
排除标准
- •Participants over 85 years of age
- •Participants with the inability to swallow pills and capsules.
- •Participants with a strong gag reflex
- •Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
- •Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a pregnancy test.
结局指标
主要结局
Assessment of quality and performance of Compact Imaging System (CIS)
时间窗: 5-7 Minutes of imaging
Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system
次要结局
未报告次要终点
研究者
Guillermo Tearney
Professor of Pathology
Massachusetts General Hospital