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

Summary: 
      The purpose of this study is to evaluate the effect of a modified Prep and procedure on colon
      cleansing level and capsule 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 Given® Diagnostic System 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 RF transmitter. Advantages of the Given® Diagnostic System
      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 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 FDA-approved 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 processional
      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. 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 compare the levels of cleanliness and visualization
      of colon achieved by colon capsule endoscopy when using different regimens for preparation of
      the colon. Furthermore, capsule colonoscopy and colonoscopy procedures will be compared in
      regards to the level of colon cleanliness and detection of lesions in the colon.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that are indicated for colonoscopy, who are suspected or known to suffer from
        colonic diseases
      
Keywords: Colonic Diseases