JPRN-UMIN000007258已完成3 期
Study of the clinical usefulness of the PC2-101 Colon Capsule Endoscopy in the detection of lesion of the colon - Study of the clinical usefulness of Colon Capsule Endoscopy
Given Imaging K.K.0 个研究点目标入组 72 人开始时间: 2012年2月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Individuals 1. who have dysphasia 2. who have known or suspected occlusion, stenosis, or a fistula of the digestive tract in abdominal x-ray test, abdominal ultrasound test, in their medical/ surgical history, in their clinical findings, or the like (this excludes cases where determination was not possible using the methods indicated above, but possible to confirm the absence of stenosis in small intestine double contrast testination including simple method) 3. who received radiological treatment of the pelvic viscera and with suspected stenosis due to radiological enterocolitis 4. who have a history of surgical procedure within the abdominal cavity (e.g. colostomy procedure or bypass procedure) and for whom the absence of any problem in carrying out the present investigation cannot be confirmed with appropriate test including small bowel test 5. who have embedded electrical endoscopic or surgical device, e.g. a cardiac pacemaker 6. with scheduled MRI test 7. with known gastrointestinal motility function disorder that makes it difficult to carry out this study 8. with known delayed gastric emptying that makes it difficult to carry out this study 9. with history of long-term administration of NSAIDs and with suspected of having a stenosis due to bowel disease caused by the NSAIDs 10. with a serious heart condition 11. with any type of allergy or warning/contraindication against the drugs to be used in this study 12. who are/may be pregnant or breastfeeding, 13. whose clinical condition may not enable to carry out required items from the study protocol or that may limit participation in the study 14. with fatal conditions 15. with lesions for which surgical treatment is necessary, and which may become advanced rapidly. 16. with scheduled participation in other clinical studies during the clinical study duration. 17. who clinical study principal investigator, or subinvestigator has determined are not suitable for participation in this study
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