NCT01576120

Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients

Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients- Pivotal Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.

Detailed description

1. Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients. Secondary Objective To evaluate safety of the PillCam™ 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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	bowel prep regimen first boost 6 oz. and second boost 3 oz.	Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)
OTHER	bowel prep regimen first boost 3 oz. and second boost 6 oz.	Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-04-12
• Last updated: 2019-08-08
• Results posted: 2014-10-09

Locations

2 sites across 1 country: United States