Safety Evaluation of Bowel Cleansing Regimen for PillCamĀ® COLON 2 Capsule Endoscopy
Information source: Given Imaging Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: The preparation regimen (Other)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Given Imaging Ltd. Official(s) and/or principal investigator(s): PANKAJ K. KASHYAP, M.D., Principal Investigator, Affiliation: Pinnacle Research Group, LLC
Summary
This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2
Capsule Endoscopy.
Clinical Details
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: 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.
Detailed description:
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.
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subject is between 50 - 75 years of age.
2. Subject is healthy without any known disease, or any current symptoms of any disease
or other abnormal condition.
3. Subject received an explanation about the nature of the study and agrees to provide
written informed consent.
4. Subject has normal serum chemistry tests at baseline.
Exclusion Criteria:
1. Subject has any allergy or other known contraindication to the medications used in
the study.
2. Subject with history or clinical evidence of renal disease and/or previous clinically
significant laboratory abnormalities of renal function parameters.
3. Subject has Type 1 or Type II Diabetes.
4. Subject has any condition which precludes compliance with study instructions.
5. Women who are either pregnant or nursing at the time of screening, or are of
child-bearing potential and do not practice medically acceptable methods of
contraception.
6. Subject suffers from life threatening conditions.
7. Concurrent participation in another clinical trial using any investigational drug or
device.
Locations and Contacts
Pinnacle Research Group, LLC, Anniston, Alabama 36207, United States
Additional Information
Given Imaging website Pinnacle Research Group website
Starting date: March 2012
Last updated: July 4, 2012
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