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

Summary: 
      To evaluate the effect of a modified preparation and procedure on colon cleansing level
    

Detailed description: 
      The evaluation of subjects with suspected colonic disease includes endoscopic imaging by
      colonoscopy and radiologic imaging 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 using capsule endoscopy, a swallowable 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 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 FDA-approved in August 2001 for
      small bowel evaluation has been ingested to date by more than 300,000 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 capsule colonoscopy and colonoscopy
      procedures with respect to colon cleansing level and progression of colon capsule.
      Furthermore, the two procedures will be compared in regards to the detection of colon
      abnormalities.
    

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