Multicenter prospective registration study of efficacy and safety of capsule endoscopy in Crohn's disease patient in Japan. (SPREAD-J study)
Not Applicable
Completed
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000037143
- Lead Sponsor
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with unknown digestive tract patency and patients with gastrointestinal obstruction or fistula. 2) Patients who can not receive CE (Patients with cardiac pacemaker insertion, or other electronic medical devices, or dysphagia or dysphagia symptoms). 3) Patients who are pregnant and may be pregnant. 4) In addition, patients who were judged to be unable to participate in research by responsible researcher or shared doctor.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection rate and frequency of Crohn's disease lesions by capsule endoscopy (CE)
- Secondary Outcome Measures
Name Time Method Correlativity of existing Crohn's disease lesion activity evaluation methods (CDAI, CECDAI, Lewis Score), frequency of adverse events, capsule endoscopy acceptance evaluation, usage of patency capsules, and patency capsule related Adverse events