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 sites60 target enrollmentFebruary 16, 2015

ConditionsConditions 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.

Overview

Phase: 未知
Intervention: Not specified
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.
Sponsor: Department of Gastroenterology, Fukushima Medical University Aizu Medical Center
Enrollment: 60
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 16, 2015

End Date

March 31, 2016

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Department of Gastroenterology, Fukushima Medical University Aizu Medical Center

Eligibility Criteria

Inclusion Criteria

Not provided

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.