NCT01942720

Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure

Detailed description

This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months . Up to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\\or adult subjects with known Crohn's disease

Conditions

• Known Crohn Disease Subjects

Interventions

Type	Name	Description
DEVICE	Capsule endoscopy and Ileocolonoscopy tests

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-09-16
• Last updated: 2017-05-31
• Results posted: 2017-05-31

Locations

15 sites across 1 country: United States