NCT01552200

Performance Evaluation of the NaviAid™ G-Eye System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Smart Medical Systems Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Colorectal Cancer
• Polyp
• Adenoma

Interventions

Type	Name	Description
PROCEDURE	Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure	Standard Colonoscopy,NaviAid™ G-Eye procedure
PROCEDURE	Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy	G-Eye procedure, Standard Colonoscopy

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-03-13
• Last updated: 2014-04-08

Locations

4 sites across 2 countries: Germany, Israel