Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure|
- Colon cleansing level score [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Number of colon capsules excreted over time [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Accuracy parameters of PCCE, compared to colonoscopy. [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Number, type and severity of adverse events [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Patient subjective assessment questionnaires [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Physician assessment questionnaire [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases.
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 offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, an ingestible device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the PillCam platform include the elimination of the need for sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the PillCam platform may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.
The PillCam™ SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for small bowel evaluation has been ingested to date by more than 500,000 people worldwide and is well accepted by patients and physicians as well as the processional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the PillCam platform to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. Further details of the PillCam™ Colon Capsule Endoscope (PCCE) can be found in the device description section.
This is a pilot study that is designed to compare the levels of cleanliness and visualization of colon achieved by colon capsule endoscopy when using two different regimens for preparation of the colon. Furthermore, capsule colonoscopy and colonoscopy procedures will be compared in regards to the level of colon cleanliness and detection of lesions in the colon. The study will be conducted in 2 phases: pilot phase in which the optimal procedure will be determined following a comparison of the two procedures. The second phase will be a validation of the proposed procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885339
|Centro Ricerca e Formazione ad Alta Tecnologia nelle Scienze Bomediche|
|Campobasso, Italy, 86100|
|Humanitas Istituto Clinico|
|Milano, Italy, 20089|
|Ospedale Maggiore - Policlinico|
|Milano, Italy, 2100|
|Universita Cattolica del Sacro Cuore|
|Roma, Italy, 00168|
|Principal Investigator:||Guido Costamagna, Prof. Dr.||Catholic University of the Sacred Heart|