Pilot Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Ability of the R-TCE capsule to acquire quality images of the lower GI tract
研究概览
简要总结
The investigators have developed an inexpensive tool to take pictures in the lower GI tract without sedation and to look for signs of disease. The tool is a capsule, about the size of a fish oil or multi-vitamin supplement, attached to a string. The capsule and string are connected to a motor to allow the capsule to advance up the participant's lower GI tract. The capsule will be inserted into the participant's lower GI tract and advance upward via a slow spiral motion. The capsule is connected to an imaging system that saves and displays the images in real time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are 18 years of age or older.
- •Are healthy or with a confirmed diagnosis of Lynch Syndrome
- •Are capable of giving informed consent.
- •Are able to follow bowel prep instructions
- •Had a colonoscopy 0-24 months prior that did not show any abnormalities or individuals who report no gastrointestinal symptoms and no knowledge of any lower GI tract disease or abnormality and volunteer through Rally.
排除标准
- •Who are over 75 years of age or older
- •With a history or current diagnosis of colonic and/or anal strictures
- •With a current diagnosis of any bleeding disorders
- •Who currently use drugs that interfere with coagulation (excluding low-dose aspirin)
- •With a history or current diagnosis of colorectal cancer
- •With a history or current diagnosis of diverticulosis or diverticulitis
- •With any prior anorectal, colorectal, or colonic surgery
- •With a history of volvulus or torsion
- •Who are pregnant
- •With contraindications to bowel prep or colonoscopy
- •With severe acute inflammatory bowel disease
- •With large hemorrhoids or hemorrhoidal bleeding or banding
结局指标
主要结局
Ability of the R-TCE capsule to acquire quality images of the lower GI tract
时间窗: Imaging data is collected during the study procedure and analyzed within one year of collection.
Ability of the R-TCE capsule to acquire quality images of the lower GI tract
时间窗: Imaging data is collected during the study procedure and analyzed within one year of collection.
次要结局
- Tolerability of the R-TCE Capsule in an unsedated participant(Day 1)
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital