Evaluation of PillCam™ Colon 2 in Visualization of the Colon
- Conditions
- Colonic Diseasesand Large Bowel Diseases
- Interventions
- Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule
- Registration Number
- NCT01063231
- Lead Sponsor
- Medtronic - MITG
- Brief Summary
Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 PillCam™ (Capsule Endoscopy) Colon 2 capsule Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
- Primary Outcome Measures
Name Time Method Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps ≥6mm and ≥10 mm as compared to conventional colonoscopy within 7 days
- Secondary Outcome Measures
Name Time Method Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos within 7 days Capsule transit time within stomach, small bowel and colon based on Rapid videos within 7 days Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy within 7 days Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy within 7 days Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy Within 7 days RAPID reading time Number, type and severity of adverse events with in 7 days
Trial Locations
- Locations (8)
Hospital Erasme - Gastro-Enterologie
🇧🇪Brussels, Belgium
Academic Medical Center University of Amsterdam
🇳🇱Amsterdam, Netherlands
Chef de Service dHepato-Gastro-Enterologie et dAssistance Nutritionnelle CHU Nantes
🇫🇷Nantes, France
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Evangelisches Krankenhaus
🇩🇪Dusseldorf, Germany
Ospedale Gemelli,ENDOSCOPIA DIGESTIVA
🇮🇹Roma, Italy
Malmo University Hospital
🇸🇪Malmo, Sweden
CHU Nancy
🇫🇷Vandoeuvre Cedex, France