Evaluation of the PillCam™ Colon Capsule -2 System
Condition: Bowel Diseases
MeSH terms: Intestinal Diseases
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect
      polyps and other pathologies in the colon.
    

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 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects that are indicated for colonoscopy, who are suspected or known to suffer from
        large bowel diseases.
      
Keywords: Bowel Diseases