Investigation of efficacy and safety in magnetically guided capsule endoscope system for stomach inspectio
- Conditions
- Conditions are as follows. 1. Tumor (adenoma, early cancer, advanced cancer) 2. Ulcer (including ulcer scar) 3. Fundic gland polyp 4. Hyperplastic polyp 5. Post endoscopic therapy for stomach tumor 6. Portal hypertensive gastropathy 7. Submucosal tumor 8. Varices 9. Or people with no symptoms who desire capsule endoscopic inspection.
- Registration Number
- JPRN-UMIN000016556
- Lead Sponsor
- Department of Gastroenterology, Fukushima Medical University Aizu Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of capsule endoscopy to major diseases of stomach (adenoma, early cancer, advanced cancer)
- Secondary Outcome Measures
Name Time Method