Status:
COMPLETED
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
Lead Sponsor:
Medtronic - MITG
Conditions:
Colonic Diseases
Eligibility:
All Genders
18-50 years
Brief Summary
The purpose of this study is to evaluate the effect of a modified Prep and procedure on colon cleansing level and capsule excretion rate.
Detailed Description
The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography . The Given® Diagnosti...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Subject is between the ages of 50-75 years and clinically indicated for conventional colonoscopy-
- Subject is 18-50 years of age suspected /known to suffer from colonic disease and was referred for colonoscopy for any standard indication including, but not limited to: rectal bleeding, melena, positive stool testing for occult blood, recent change of bowel habits, screening for colorectal cancer, ulcerative colitis, signs of colonic lesions on an imaging study)-
- No more than 25% of subjects (for each site) will be recruited from group B with a minimum of 20%
Exclusion
- The presence of any of the following will exclude a subject from study enrollment:
- 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 not eligible for colon preparation with sodium phosphate solution due to the presence of underlying conditions according to the clinical judgment of the investigator.
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00885209
Start Date
February 1 2008
End Date
March 1 2009
Last Update
July 31 2019
Active Locations (5)
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1
Hospital del Mar
Barcelona, Spain, 08003
2
Hospital Clinic i Provincial
Barcelona, Spain, 08036
3
Hospital Georio Maranon
Madrid, Spain, 28007
4
Hospital Clinico San Carlos
Madrid, Spain, 28040