The Clinical Application of MCCES in Examination of Human Colon
2015年8月26日 更新者：Nanfang Hospital of Southern Medical University
The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510515
- 招聘中
- Nanfang Hospital of Southern Medical University
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接触：
- huiling Zheng, master
- 电话号码：+86 15013113215
- 邮箱：bywxling@163.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or
- Patients who volunteer to the colonoscopy screening.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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有源比较器：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.
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Maneuverability
大体时间：From the MCCES examination began until the capsule excreted, an expected average of 24h
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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.
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From the MCCES examination began until the capsule excreted, an expected average of 24h
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Migration length of anus direction
大体时间：From the MCCES examination began until the capsule excreted, an expected average of 24h
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Migration length of anus direction was defined as how long was the distance the capsule controlled by the Magnetic-manipulator moved from cecum to anus in 25 minutes.
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From the MCCES examination began until the capsule excreted, an expected average of 24h
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The movement of mouth direction
大体时间：From the MCCES examination began until the capsule excreted, an expected average of 24h
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The movement of mouth direction was defined as if the capsule controlled by the Magnetic-manipulator could move from any point of the colon towards mouth direction.
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From the MCCES examination began until the capsule excreted, an expected average of 24h
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Nidus of colon
大体时间：During the procedure
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From date of the examination until the date of pathological diagnosis, an expected average of 7 days
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During the procedure
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The level of cleanliness
大体时间：From the MCCES examination began until the capsule excreted, an expected average of 24h
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The cleanliness of the colon was graded as excellent (No more than small bits of adherent feces),good(Small amount of feces or dark fluid,but not enough to interfere with the examination ),fair(Enough feces or dark fluid present to preclude a completely reliable examination),poor(large amount of fecal residue).
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From the MCCES examination began until the capsule excreted, an expected average of 24h
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Procedure related complication
大体时间：From the day of the examination until the follow up ended ,access up to 7 days.
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Perforation, capsule retention, abdominal pain and so .etc.
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From the day of the examination until the follow up ended ,access up to 7 days.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bo Jiang, doctor、Nanfang Hospital of Southern Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Spada C, Hassan C, Ingrosso M, Repici A, Riccioni ME, Pennazio M, Pirozzi GA, Pagano N, Cesaro P, Spera G, Petruzziello L, Costamagna G. A new regimen of bowel preparation for PillCam colon capsule endoscopy: a pilot study. Dig Liver Dis. 2011 Apr;43(4):300-4. doi: 10.1016/j.dld.2010.10.005. Epub 2010 Nov 18.
- Hagel AF, Gabele E, Raithel M, Hagel WH, Albrecht H, de Rossi TM, Singer C, Schneider T, Neurath MF, Farnbacher MJ. Colon capsule endoscopy: detection of colonic polyps compared with conventional colonoscopy and visualization of extracolonic pathologies. Can J Gastroenterol Hepatol. 2014 Feb;28(2):77-82. doi: 10.1155/2014/691785.
- Gu H, Zheng H, Cui X, Huang Y, Jiang B. Maneuverability and safety of a magnetic-controlled capsule endoscopy system to examine the human colon under real-time monitoring by colonoscopy: a pilot study (with video). Gastrointest Endosc. 2017 Feb;85(2):438-443. doi: 10.1016/j.gie.2016.07.053. Epub 2016 Jul 29.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年8月1日
初级完成 (预期的)
2015年9月1日
研究完成 (预期的)
2015年9月1日
研究注册日期
首次提交
2015年8月24日
首先提交符合 QC 标准的
2015年8月26日
首次发布 (估计)
2015年8月31日
研究记录更新
最后更新发布 (估计)
2015年8月31日
上次提交的符合 QC 标准的更新
2015年8月26日
最后验证
2015年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.