Evaluation of PillCam™ Colon 2 in Visualization of the Colon
Condition: Colonic Diseases; and Large Bowel Diseases
MeSH terms: Intestinal Diseases; Colonic Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): PillCam™ (Capsule Endoscopy) Colon 2 capsule
Intervention type(s): Device
Intervention description(s): Medical Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colonic Diseases; bowel diseases