Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis
Condition: Colonic Disease; Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Colonic Diseases; Ulcer
Study type: Observational

Summary: 
      To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify
      Ulcerative colitis
    

Detailed description: 
      Ulcerative colitis (UC) is a disorder of unknown origin that may be characterized by acute
      and chronic inflammation of the colon. The extent of the colonic mucosal inflammation varies
      among individuals, but the disease almost always involves the rectum. Ulcerative colitis has
      required evaluation by colonoscopy to determine the extent and severity of the disease. The
      PillCam platform 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 PillCam platform 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 PillCam platform may be more readily accepted by the
      subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the
      colon.

      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 700,000 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. Further details of
      the PillCam® Colon Capsule Endoscope (PCCE) can be found in the device description section.

      In previous studies, the PillCam colon platform has been shown to be safe and to be able to
      demonstrate colon polyps and cancers. This study is an extension to a trial evaluating the
      use of PCCE in ulcerative colitis that has already been completed in Hong Kong (n=40). This
      study is designed to assess the ability of the capsule to accurately detect inflammatory
      lesions and thus classifying the extent and severity of disease in subjects with ulcerative
      colitis in comparison to traditional colonoscopy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative
        colitis disease

        The study population will consist of subjects who fulfill all the inclusion criteria and
        none of the exclusion criteria.
      
Keywords: Colonic disease; Ulcerative colitis; suspected or known colonic disease