Performance Evaluation of the NaviAid™ G-Eye System
|Colorectal Cancer Polyp Adenoma||Procedure: Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure Procedure: Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Performance Evaluation of the NaviAid™ G-Eye System|
- 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 ]
|Study Start Date:||June 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: A-Standard Colonoscopy, G-Eye procedure
Standard Colonoscopy,G-Eye procedure
Procedure: Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure
Standard Colonoscopy,NaviAid™ G-Eye procedure
Active Comparator: B- G-Eye procedure, Standard Colonoscopy
G-Eye procedure,Standard Colonoscopy
Procedure: Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy
G-Eye procedure, Standard 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 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 complete NaviAid™ G-Eye procedure will be performed by the same endoscopist.
Group B: Subjects will undergo a complete NaviAid™ G-Eye procedure as the first procedure. Immediately after the NaviAid™ G-Eye procedure, a complete standard colonoscopy will be performed by the same endoscopist.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552200
|St. Marienkrankenhaus Frankfurt|
|Frankfurt, Germany, 60318|
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Netanya, Israel, 42150|
|Tel Aviv Sourasky Medical Center|
|Tel Aviv, Israel, 64239|
|Principal Investigator:||Erwin Santo, MD||Tel-Aviv Sourasky Medical Center|
|Principal Investigator:||Beny Shpak, MD||Laniado Hospital|
|Principal Investigator:||Yael Kopelman, MD||Hadassah Medical Organization|