Status:
COMPLETED
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
Lead Sponsor:
Medtronic - MITG
Conditions:
Colonic Diseases
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to compare two preparation and procedure in order to develop the most optimal capsule procedure in regards to 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 PillCam platform ...
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, ulcerative colitis, colonic findings on an imaging study)
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 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 :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00885339
Start Date
February 1 2008
End Date
October 1 2009
Last Update
July 31 2019
Active Locations (4)
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1
Centro Ricerca e Formazione ad Alta Tecnologia nelle Scienze Bomediche
Campobasso, Italy, 86100
2
Humanitas Istituto Clinico
Milan, Italy, 20089
3
Ospedale Maggiore - Policlinico
Milan, Italy, 2100
4
Universita Cattolica del Sacro Cuore
Roma, Italy, 00168