Spots Global Cancer Trial Database for First in Man Aer-O-Scope

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Trial Identification

Brief Title: First in Man Aer-O-Scope

Official Title: A Single-center Study to Evaluate the Safety & Performance of the Aer-O-Scope for Traveling Through the Colon in Healthy Volunteers

Study ID: NCT02102412

Conditions

Screening Colonoscopy for Low Risk Subjects

Interventions

screening colonoscopy

Study Description

Brief Summary: A single center study intended to evaluate the Aer-O-Scope Colonoscope System.

Detailed Description: A clinical study in Zagreb Croatia, intended to evaluate the Aer-O-Scope Colonoscope System. The study includes 120 subjects and has the following endpoints: Evaluation of the Aer-O-Scope advancement, imaging and retraction throughout the Colon. Safety: No occurrence of any device related major adverse event (for details see section 9.5) Efficacy: 1. Advancement of device towards the ceacum and retraction 2. Visualization of the colon mucosa by the traveling imaging device 3. Procedure duration 4. Handling and operation (assessment by operator)