Evaluation of PillCam™ Colon 2 in Visualization of the Colon
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01063231|
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : November 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Colonic Diseases and Large Bowel Diseases||Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of PillCam™ Colon 2 in Visualization of the Colon|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2010|
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule
- 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 ]
- Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy [ Time Frame: within 7 days ]
- Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy [ Time Frame: within 7 days ]
- Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos [ Time Frame: within 7 days ]
- Capsule transit time within stomach, small bowel and colon based on Rapid videos [ Time Frame: within 7 days ]
- Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy [ Time Frame: Within 7 days ]
- RAPID reading time Number, type and severity of adverse events [ Time Frame: with in 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|