Ulcerative Colitis Clinical Trial
Official title:
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis
To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify Ulcerative colitis
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.
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