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

Completed · Phase 1/Phase 2

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01575093

Run by

Medtronic - MITG

People needed

25

Starts

2012-03-01

Expected to finish

2012-06-01

Last updated by the study team

2019-07-31

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is between 50 - 75 years of age.
• Subject is healthy without any known disease, or any current symptoms of any disease or other abnormal condition.
• Subject received an explanation about the nature of the study and agrees to provide written informed consent.
• Subject has normal serum chemistry tests at baseline.

You may not qualify if…

• Subject has any allergy or other known contraindication to the medications used in the study.
• Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
• Subject has Type 1 or Type II Diabetes.
• Subject has any condition which precludes compliance with study instructions.
• 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.
• Subject suffers from life threatening conditions.
• Concurrent participation in another clinical trial using any investigational drug or device.

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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