JPRN-UMIN000016556已完成未知
Investigation of efficacy and safety in magnetically guided capsule endoscope system for stomach inspection - Investigation of magnetically guided capsule endoscope system for stomach inspection
Department of Gastroenterology, Fukushima Medical University Aizu Medical Center0 个研究点目标入组 60 人开始时间: 2015年2月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Subjects diagnosed or suspected as stricture, adhesion, diverticulum, ileus, or fistula of the intestine. 2)Subjects with history of ileus or stricture. 3)Subjects diagnosed as Crohn disease 4)Subjects with gastrointestinal stasis. 5)Pregnant females 6)Subjects being unable to undergo surgery 7)Subjects being unable to intake capsule (11mm (Outer diameter)by13mm (length)) 8)Subjects with deglutition disorder, or Zenker diverticulum. 9)Subjects with Zenker diverticulum. 10)Subjects who undergo gastro- intestinal bypass surgery. 11)Subjects with intestinal stent and others which lead to be obstruction to passage of capsule. 12)Subjects with severe esophageal hiatal hernia. 13)Subjects with life-threatening illness. 14)Subjects with severe cardiac arrest, or respiration failure. 15)Subjects undergoing several surgeries or radiation therapies, except for subject judged as appropriate candidate for the trial by the investigators. 16)Subjects participating in other trials 17)Subjects being unable to observe instructions concerning this trial. 18)Subjects with implant described as below. 1. Metallic artificial cardiac valve 2. Artificial ear, or auditory ossicle. 3. Nerve or bone growth stimulator. 4. Perfusion pump. 5. Magnetic stent. 6. Brain aneurysm clip 7. ventricular shunt tube 8. Magnetic wire of eyelids 9. Magnetic artificial eye 10. Cardiac pacemaker 11. Defibrillator. 12. Other implanted electronic device. 19)Subjects with medical products containing metal component abdominally or in low back. 20)Subjects judged as inappropriate candidates for the trial by the investigators.
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