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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
25
Regimen includes administration of 4 Senna tablets 2 days before the procedure, 2-liters of PEG on the evening before the procedure, 2-liters of PEG on the morning of the procedure, 10mg Metoclopramide, two boosts (6-oz and 3-oz) of SUPREP oral sulfate solution and a 10mg Bisacodyl suppository
Pinnacle Research Group, LLC
Anniston, Alabama, United States
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.
Safety will be evaluated by number of Adverse Events and percentage of subjects with clinically siginifcant change in serum chemistry test.
Time frame: Latest blood test conducted (i.e. 24 hours after suppository or seven days after procedure)
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