Crohn's Disease Clinical Trial
Official title:
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients- Pivotal Study
The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.
1. Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep
Regimen in CD patients.
Secondary Objective To evaluate safety of the PillCamâ„¢ COLON 2 procedure in CD patients
2. Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small
bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and
colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to
evacuate all fecal matter prior to the exam and in order to propel the capsule and
complete its traverse through the entire GI track within examination time.
3. The study is designed to evaluate the effectiveness of the prep regimen in terms of
transit, excretion and cleansing in CD patients
All end points will be evaluated within 4 months from end of enrollment.
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