The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Maneuverability
研究概览
简要总结
This study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application.
详细描述
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the Western world. The screening tests include flexible sigmoidoscopy, optical colonoscopy (OC), double-contrast barium enema , or CT colonography . Such screening can reduce CRC incidence and mortality but its effectiveness depends on its quality, ease of use, and patient adherence .Colon capsule endoscopy(CCE) is being actively evaluated as an emerging complementary or alternative procedure for evaluation of the colon. magnetic -controlled capsule endoscopy system is a new ingestible colon capsule robot provided by Chongqing Jinshan Science & Technology. While Screening the colon, the capsule is drove by magnetic-manipulator outside the body, which means it can move from the cecum to anus step by step under the control of the doctor. However, there's little data report on this colon capsule robot system in clinical application. The investigators plan to conduct this prospective study to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or
- •Patients who volunteer to the colonoscopy screening.
排除标准
- •Dysphagia or swallowing disorder,
- •Congestive heart failure,
- •Renal insufficiency,
- •Prior major abdominal surgery of the gastrointestinal tract,
- •Known or suspected bowel obstruction,
- •Presence of a cardiac pacemaker or other implanted electromedical devices,
- •Allergy or contraindication to the medications used in the study.
研究组 & 干预措施
MCCES
Magnetic -controlled capsule endoscopy system (MCCES) is a robot system that the capsule would be swallowed to observe the mucosa of the human alimentary canal especially the colon under the control of the magnetic-manipulator.
干预措施: magnetic-controlled capsule endoscopy system (Procedure)
Colonoscopy
Colonoscopy has now been in use for many years to visualize and diagnose abnormalities of the colon and it is the gold standard for detecting colorectal lesions.In this study,the additional utility of the colonoscopy is to monitor the movement of the Magnetic -controlled capsule endoscopy.
干预措施: Colonoscopy (Procedure)
结局指标
主要结局
Maneuverability
时间窗: From the MCCES examination began until the capsule excreted, an expected average of 24h
The Maneuverability was defined as the rotation, somersault, Bird's-eye view, worm's eye view of the capsule, and completing any motion would gain 1 point, eventually ,4 point was good,2-3 point moderate,0-1point poor.
次要结局
- Migration length of anus direction(From the MCCES examination began until the capsule excreted, an expected average of 24h)
- The movement of mouth direction(From the MCCES examination began until the capsule excreted, an expected average of 24h)
- The level of cleanliness(From the MCCES examination began until the capsule excreted, an expected average of 24h)
- Procedure related complication(From the day of the examination until the follow up ended ,access up to 7 days.)
- Nidus of colon(During the procedure)