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Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy
This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.
Details
| Lead sponsor | Medtronic - MITG |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2012-03 |
| Completion | 2012-06 |
Conditions
- Healthy Volunteers
Interventions
- The preparation regimen
Primary outcomes
- To evaluate the safety of a bowel preparation regimen comprised of Sulfate free Polyethylene glycol electrolyte lavage solution (SF-PEG) plus SUPREP oral sulfate solution as a "booster", in adult subjects. — Latest blood test conducted (i.e. 24 hours after suppository or seven days after procedure)
Safety will be evaluated by number of Adverse Events and percentage of subjects with clinically siginifcant change in serum chemistry test.
Countries
United States