Evaluation of the PillCam™ Colon Capsule -2 System
|ClinicalTrials.gov Identifier: NCT00884624|
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : March 11, 2010
|Condition or disease|
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 500,000 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 PillCam™ Colon Endoscope 1(PCCE-1) system. The new development of PillCam Colon Endoscope 2 (PCCE-2) is primarily aimed to increase sensitivity and specificity for polyp detection.
Further details of the PillCam™ Colon Capsule Endoscope (PCCE-2) can be found in the device description section.
This study is designed to evaluate the performance of the new version of colon capsule and its performance in detecting lesions in the colon as compared to conventional colonoscopy.
|Study Type :||Observational|
|Actual Enrollment :||255 participants|
|Official Title:||Evaluation of the PillCam™ Colon Capsule -2 System|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
- Accuracy parameters of PCCE-2 in detecting colonic polyps as compared to conventional colonoscopy [ Time Frame: Within 7 Days ]
- Assessment of colon cleansing level at different colon segments [ Time Frame: Within 7 days ]
- Distribution of capsule excretion time [ Time Frame: Within 7 Days ]
- Percent of excreted capsules up to 10 hours post capsule ingestion. [ Time Frame: Within 7 Days ]
- Number, type and severity of adverse events [ Time Frame: WithIn 7 days ]
- Accuracy parameters of PCCE-2 in detecting colonic lesions as compared to conventional colonoscopy [ Time Frame: within 7 days ]
- Capsule transit time within stomach, small bowel and colon [ Time Frame: within 7 days ]
- Number of polyps and sizes at different colon segments detected by capsule [ Time Frame: within 7 days ]
- Number of polyps and sizes at different colon segments detected by conventional colonoscopy [ Time Frame: within 7 days ]
- RAPID video reading time [ Time Frame: Within 7 days ]
- Conventional colonoscopy duration including: total time, insertion time, and withdrawal time see my comment above (at the objective section) [ Time Frame: Within 7 Days ]
- Assessment of the RAPID video [ Time Frame: Within 7 Days ]
- Patient questionnaire [ Time Frame: Within 7 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884624
|Hillel Yaffe Hospital|
|Hadera, Israel, 38101|
|Rambam - Medical center|
|Haifa, Israel, 31096|
|Bikkur Holim Hospital|
|Meir Medical Center|
|Kfar Saba, Israel, 95347|
|Rabin Medical Center|
|Petach Tikva, Israel, 49100|
|Principal Investigator:||Rami Eliakim, Prof.||Rambam Health Care Campus|