CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
Pillcam colon capsule and PillCam™ Prep Procedure +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01631435
NCT01631435Phase 2Completed

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

Medtronic - MITG·interventional·Posted Jun 29, 2012·Updated Aug 1, 2019

In Brief

A Phase 2 clinical trial evaluating Pillcam colon capsule and PillCam™ Prep Procedure and Ileocolonoscopy for Crohn's Disease. Completed, enrolled 75 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2012
Enrollment StartJun 1, 2012
Primary CompletionJan 1, 2014
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.0 years ago

Interventions

Pillcam colon capsule and PillCam™ Prep Procedureother

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.

Ileocolonoscopydevice

Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure • Ileocolonoscopy with intubation of terminal ileum