PillCam® Platform With the PillCam Crohn's Disease Capsule

Status Completed

Clinical Trial Summary

This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).

Clinical Trial Description

This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below:

Visit 1; Screening visit

- Informed consent process

- screening for eligibility to participate in the study

- Inclusion/exclusion criteria

- Small bowel patency test

- Demographic data

- Pregnancy test

- General medical history

Visit 2; PillCam® Crohn's capsule ingestion

- PillCam® CD bowel preparation

- Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)

- Ileocolonoscopy with intubation of terminal ileum

Follow up period (5-9 days following visit 2)

• CE Follow up telephone contac ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01631435
Study type	Interventional
Source	Medtronic - MITG
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	June 2012
Completion date	February 2014

View Details

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