Clinical Trial: Performance Evaluation of the NaviAid™ G-Eye System
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Performance Evaluation of the NaviAid™ G-Eye System
Brief Summary: The purpose of this study is to compare the additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure.
Detailed Summary:
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 multicenter, two-arm, randomized, open-label study intended to compare the additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure.
Subjects will be randomized to one of two groups: Group A, the "Study Group," and Group B, the "Control Group."
Group A: Subjects will undergo a complete standard colonoscopy as the first procedure. Immediately after the standard colonoscopy procedure, a c
Sponsor: Smart Medical Systems Ltd.
Current Primary Outcome: NaviAid™ G-Eye procedure adenoma detection rate compared to the standard colonoscopy procedure adenoma detection rate [ 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 ]
Original Primary Outcome: The purpose of this study is to compare the additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure. [ 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 ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Smart Medical Systems Ltd.
Dates:
Date Received: March 6, 2012
Date Started: June 2012
Date Completion:
Last Updated: April 6, 2014
Last Verified: April 2014
