Colonic Diseases Clinical Trial
Official title:
Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
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.
This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting
colon abnormalities. Note that the physician performing the capsule endoscopy and reading the
capsule videos and the physician performing the colonoscopy were unaware of each other's
findings until completion of the examinations and reports (assessor-blind).
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