NCT01631435

PillCam® Platform With the PillCam Crohn's Disease Capsule

Evaluation of the PillCam® Platform With the PillCam Crohn's Disease Capsule in Visualization of Lesions in the Small Bowel and Colon That May Indicate Crohn's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	Pillcam colon capsule and PillCam™ Prep Procedure	PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
DEVICE	Ileocolonoscopy	Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure • Ileocolonoscopy with intubation of terminal ileum

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2012-06-29
• Last updated: 2019-08-01
• Results posted: 2015-03-27

Locations

1 site across 1 country: United States