Status:
COMPLETED
PillCam Colon Capsule and CT-colonography in the Evaluation of Patients With Incomplete Conventional Colonoscopy
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Colorectal cancer (CRC) is the second most common cause of cancer-related death in the Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary CRC screening tool in ...
Detailed Description
Colorectal cancer (CRC) is the second most common cause of cancer-related death in the Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary CRC screening tool in ...
Eligibility Criteria
Inclusion
- Subject is between the ages of 18-75 years.
- Subject is referred for colonoscopy as clinically indicated for any reason. This may include, but not limited to, the investigation of any of the following conditions: rectal bleeding, melena, positive stool testing for occult blood, recent change of bowel habits, screening for colorectal cancer, colonic findings on an imaging study
- Subject in which conventional colonoscopy was incomplete
Exclusion
- Subject has dysphagia or any swallowing disorder
- Subject has Congestive heart failure
- Subject has high degree of renal insufficiency
- Subject has had prior abdominal surgery of the gastrointestinal tract 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 electromedical 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, or NSAID enteropathy,
- 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, who intend to be during the study period, 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
- Iodine contrast allergy
- Hyperthyroidism
- Inflammatory bowel disease
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01525940
Start Date
November 1 2011
End Date
December 1 2013
Last Update
November 10 2015
Active Locations (1)
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1
Catholic University of Sacred Hearth
Rome, Italy, Italy, 00168