NCT02102412

First in Man Aer-O-Scope

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: GI View Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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)

Conditions

• Screening Colonoscopy for Low Risk Subjects

Interventions

Type	Name	Description
BIOLOGICAL	screening colonoscopy	performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2014-04-02
• Last updated: 2017-08-01

Locations

1 site across 1 country: Croatia