Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy|
- Number of adverse events [ Time Frame: Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure ] [ Designated as safety issue: Yes ]To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
|Study Start Date:||November 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: NaviAid™ G-Eye procedure
NaviAid™ G-Eye procedure
Device: NaviAid™ G-Eye procedure
NaviAid™ G-Eye procedure
Other Name: NaviAid™ G-Eye procedure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749722
|Haifa, Israel, 34636|
|Principal Investigator:||Ian M Gralnek, Prof.||Elisha Hospital|