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Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575093
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Description
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Brief Summary:
This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: The preparation regimen Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Arms and Interventions
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Intervention Details:
  • Other: The preparation regimen
    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

Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575093


Locations
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United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: PANKAJ K. KASHYAP, M.D. Pinnacle Research Group, LLC
More Information
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Additional Information:

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01575093    
Other Study ID Numbers: MA-112
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2012
Keywords provided by Medtronic - MITG:
Healthy volunteers