Pilot Study for Imaging of the Duodenum Using an OFDI Capsule
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
研究概览
简要总结
The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.
A total of 108 participants (36 healthy and 72 with clinically suspected or diagnosed Celiac disease) will be asked to swallow the tethered capsule, while they are awake and unsedated and ask for their feedback. Images will be taken using the OFDI system while the capsule travels from the esophagus into the stomach and into the duodenum.
详细描述
Participants including healthy volunteers as well as patients with Celiac disease will be recruited and asked to swallow the OFDI 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, through the stomach and into the duodenum using natural propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross-sectional images of the duodenum are acquired. Images are analyzed at a later stage.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be over 18 years for healthy volunteers
- •Participants must be over 16 years for patients with Celiac disease
- •Participant must be able to give informed consent
排除标准
- •Participants with an inability to swallow pills or capsules.
- •Participants with esophageal or intestinal fistulas.
- •Participants with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule.
- •Participants with a history of intestinal Crohn's disease.
- •Women who are pregnant.
结局指标
主要结局
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
时间窗: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
After participating in the study, the participant will be asked for feedback about tolerability of the procedure using a questionnaire.
Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule
时间窗: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours
An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
时间窗: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
After participating in the study, the participant will be asked for feedback about tolerability of the procedure using a questionnaire.
Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule
时间窗: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours
An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital