Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
Condition: Bowel Diseases
MeSH terms: Intestinal Diseases
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on
      colon cleansing level and excretion rate.
    

Detailed description: 
      The evaluation of subjects with suspected colonic disease includes endoscopic imaging by
      colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography. The
      PillCam® platform offers an alternative approach for endoscopic visualization of the colon
      using capsule endoscopy, an ingestible device which contains imagers, light sources, a power
      source and a radio frequency transmitter. Advantages of the PillCam® platform include the
      elimination of the need for 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 PillCam® platform may be more readily
      accepted by patients and thereby improving compliance 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 700,000 people worldwide
      and is well accepted by patients and physicians as well as the major gastrointestinal
      professional organizations. 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 specifically
      designed capsule colonoscopy procedure allows for more efficient evaluation of the colonic
      mucosa. This is expected to improve the capability of the PillCam® platform to detect colonic
      pathologies and to serve as a diagnostic and screening tool for colonic disease. Further
      details of the PillCam™ Colon Capsule Endoscope (PCCE) can be found in the device description
      section.

      This is a pilot study that is designed to develop the optimal PCCE procedure by measuring the
      levels of cleanliness and capsule excretion rates. Furthermore, capsule endoscopy and
      colonoscopy procedures will be compared in regards to the detection of polyps and lesions in
      the colon.
    

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.

        The study population will consist of subjects who fulfill at least one of the inclusion
        criteria and none of the exclusion criteria.
      
Keywords: Bowel Diseases