Spots Global Cancer Trial Database for Validation of Aer-O-Scope Colonoscope System Cecal Intubation

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Trial Identification

Brief Title: Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Official Title: Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Study ID: NCT03949777

Conditions

Interventions

Aer-O-Scope Colonoscopy

Study Description

Brief Summary: 61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation

Detailed Description: 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.