Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2012 |
| End Date: | June 2012 |
| Contact: | PANKAJ K. KASHYAP, M.D. |
| Email: | pinnacleresearch@aol.com |
This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2
Capsule Endoscopy.
The preparation regimen used for the PillCam® Colon 2 procedure consists of several colon
cleansing materials.
Different combinations of the above regimen were tested and evaluated for safety by
monitoring of adverse events in multiple clinical studies, with more than 1000 subjects
enrolled to date. No Serious Adverse Events related to the preparation were noted.
In this study, each subject will be required to undergo serum chemistry tests (blood tests)
at several time points to evaluate the safety of the regimen.
No capsule ingestion is involved.
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