Colonic Diseases Clinical Trial
Official title:
Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure
The purpose of this study is to evaluate the effect of a modified Prep and procedure on colon cleansing level and capsule excretion rate.
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.
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