Colonic Diseases Clinical Trial
Official title:
Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure
The purpose of this study is to compare two preparation and procedure in order to develop the most optimal capsule procedure in regards to 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
PillCam platform 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 PillCam platform 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 PillCam platform 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 PillCam platform 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 two 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.
The study will be conducted in 2 phases: pilot phase in which the optimal procedure will be
determined following a comparison of the two procedures. The second phase will be a
validation of the proposed procedure.
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