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.
Conditions
Interventions
Performing conventional endoscopy and capsule endoscopy to identical subject.
Sponsors
Department of Gastroenterology, Fukushima Medical University Aizu Medical Center
OLYMPUS MEDICAL SYSTEMS CORP.(only device)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient who have following stomach diseases. Major stomach diseases: 1. Tumor [adenoma, early cancer, advanced cancer] Other stomach diseases: 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 Or subjects with no symptoms who desire capsule endoscopic inspection. 2) Patient who agree to participate in this trial by written informed consent. 3) Subjects aged over 20 years old. In addition, subjects with no symptoms who desire capsule endoscopic inspection must be more than 40 years old. 4) Subjects weighing less than 135kg.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of capsule endoscopy to major diseases of stomach (adenoma, early cancer, advanced cancer) | — |
Countries
Japan
Contacts
Public ContactAtsushi Irisawa
Fukushima Medical University Aizu Medical Center Department of Gastroenterology
Outcome results
None listed