61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
This will be a prospective single-center non-blinded clinical investigation. Each subject will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All pathologies found will be removed. No control group is necessary as the main objective is to reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy procedures. Up to the first ten (10) cases for each physician will be system operation training cases. The primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
79
resection or biopsy of colonic abnormalities for histopathalogical evaluation
Sourasky Medical Center
Tel Aviv, Israel
Aer-O-Scope Validation of Cecal Intubation
The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope
Time frame: 30 minutes
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