Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
The purpose of this study is to evaluate the effect of a modified Prep and procedure on colon cleansing level and capsule excretion rate.
|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 ]
- Diagnostic yield of PCCE compared to standard colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Number of complete capsule procedure [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||February 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 Given® Diagnostic System 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 Given® Diagnostic System 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 Given® Diagnostic System 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 Given® Diagnostic System 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885209
|Hospital Clinic i Provincial|
|Barcelona, Spain, 08036|
|Hospital del Mar|
|Barcelona, Spain, 08003|
|Hospital Georio Maranon|
|Madrid, Spain, 28007|
|Hospital Clinico San Carlos|
|Madrid, Spain, 28040|
|Hospital virgen Macarena|
|Sevilla, Spain, 41071|
|Principal Investigator:||Miguel Munoz, Prof. Dr.||Clinica Universitaria de Navarra|