Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Completed · Phase 2/Phase 3

Conditions studied: Colonoscopy, Endoscopy

In brief

The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.

Key facts

Study ID

NCT01185002

Run by

Medtronic - MITG

People needed

80

Starts

2010-07-01

Expected to finish

2011-06-01

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 received an explanation about the nature of the study and agrees to provide written informed consent.

You may not qualify if…

• Subject has dysphagia or any swallowing disorder
• Subject has congestive heart failure
• Subject has Diabetes type I.
• Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
• Subject has a cardiac pacemaker or other implanted electro medical device.
• Subject has any allergy or other known contraindication to the medications used in the study
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
• Subject with gastrointestinal motility disorders
• Subject has known delayed gastric emptying
• Subject has any condition, which precludes compliance with study and/or device 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
• Subject currently participating in another clinical study

Where it is running

• Alabama Digestive Disorders Center — Huntsville, Alabama, United States
• Division of Gastroenterology Indiana University Medical Center — Indianapolis, Indiana, United States
• Research Associates of New York — New York, New York, United States
• University of North Carolina Division of Digestive Disease — Chapel Hill, North Carolina, United States
• Digestive Care, Inc. — Beavercreek, Ohio, United States
• Franklin Gastroenterology — Franklin, Tennessee, United States
• Gastroenterology Associates of Tidewater — Chesapeake, Virginia, United States

Full record on ClinicalTrials.gov

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