Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.
研究概览
简要总结
The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.
详细描述
60 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT capsule while being awake and unsedated. The capsule is attached to a 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 and later analyzed.
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 scheduled for non-urgent appointment at primary care practice including annual wellness visits and routine follow-up appointments.
- •Subjects must be over the age of 18
- •Subjects must be able to give informed consent
- •Subjects 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
- •Subjects with current symptoms of dysphagia
- •Subjects with any history of intestinal strictures, prior GI surgery, or history of intestinal Crohn's disease.
- •Subjects with current symptoms of fever, nausea or sore throat at the time of the appointment.
- •Pregnancy
结局指标
主要结局
Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.
时间窗: Approximate 20min visit (5min image acquisition)
Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital