Evaluation of PillCam™ Colon 2 in Visualization of the Colon
and Large Bowel Diseases
Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of PillCam™ Colon 2 in Visualization of the Colon|
- Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps ≥6mm and ≥10 mm as compared to conventional colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Capsule transit time within stomach, small bowel and colon based on Rapid videos [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
- RAPID reading time Number, type and severity of adverse events [ Time Frame: with in 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule
Standard evaluation of subjects with suspected colon diseases includes endoscopic imaging by colonoscopy and radiology testing such as: air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy.
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon. Advantages of the Given® Diagnostic System include the elimination of the need for conscious 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 cleared by the FDA- in August 2001 for small bowel evaluation has been ingested to date by more than 1,000,000 people worldwide and is well accepted by patients and physicians as well as the professional 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. To date, several clinical studies have been conducted with Given® Diagnostic System and the PillCam™ Colon 1 capsule A pilot multicenter study is currently being conducted with a new Given® Diagnostic System and an advanced generation of the the PillCam™ Colon capsule - PillCam™ Colon 2. Capsule. The new development of Given® Diagnostic System and PillCam™ Colon 2 capsule is primarily aimed to increase sensitivity and specificity for polyp detection.
Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section.
This study is designed to evaluate the performance of the new version of Given® Diagnostic System and PillCam™ Colon 2 capsule in detecting patients with polyps and other colonic lesions as compared to conventional colonoscopy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063231
|Hospital Erasme - Gastro-Enterologie|
|Brussels, Belgium, 1070|
|Chef de Service dHepato-Gastro-Enterologie et dAssistance Nutritionnelle CHU Nantes|
|Nantes, France, 44093|
|Vandoeuvre Cedex, France, 54511|
|Dusseldorf, Germany, 40217|
|Ospedale Gemelli,ENDOSCOPIA DIGESTIVA|
|Roma, Italy, 00168|
|Academic Medical Center University of Amsterdam|
|Amsterdam, Netherlands, 1100|
|Clinica Universitaria de Navarra|
|Pamplona, Spain, 31008|
|Malmo University Hospital|
|Principal Investigator:||Guido Costamagna, Prof.||Ospedale Gemelli|
|Principal Investigator:||Guido Costamagna, Prof||Ospedale Gemelli|