Colorectal Cancer Clinical Trial
Official title:
Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
Colonoscopy is the gold-standard method for CRC screening, as it enables detection and
real-time removal of pre-cancerous polyps during the examination. It is well known that
lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing
polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by
the colon's topography and natural folds, shallow polyps, unscreened portions of the colon
(due to incomplete colonoscopy) and endoscope slippage. The NaviAid™ G-Eye system presents a
unique concept that overcomes all 5 items listed above, providing an overall solution to the
two endoscopy key challenges of limited detection/treatment yield and limited operation
range.
The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is
permanently integrated, at its bending section. The NaviAid™ G-Eye may be used for
performing controlled withdrawal and endoscope stabilization.
A major attribute of the NaviAid™ G-Eye system controlled withdrawal technique of the
endoscope, with the balloon moderately inflated is to expand and stretch the intestinal
lumen during endoscope withdrawal.
This is a single-center, non randomized open-label study intended to evaluate the serious
adverse events prevalence when using the NaviAid™ G-Eye system during colonoscopy.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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