Screening Colonoscopy for Low Risk Subjects Clinical Trial
Official title:
A Single-center Study to Evaluate the Safety & Performance of the Aer-O-Scope for Traveling Through the Colon in Healthy Volunteers
A single center study intended to evaluate the Aer-O-Scope Colonoscope System.
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)
;