Status:
COMPLETED
Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
Lead Sponsor:
Medtronic - MITG
Conditions:
Colonoscopy
Endoscopy
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01185002
Start Date
July 1 2010
End Date
June 1 2011
Last Update
July 31 2019
Active Locations (7)
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1
Alabama Digestive Disorders Center
Huntsville, Alabama, United States, 35802
2
Division of Gastroenterology Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
3
Research Associates of New York
New York, New York, United States, 10075
4
University of North Carolina Division of Digestive Disease
Chapel Hill, North Carolina, United States, 27599