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

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)

Inclusion Criteria:

• Healthy volunteers between 18 and 65 years of age.
• Sign informed consent.

Exclusion Criteria:

• Subjects with any known GI related symptoms complaints or GI diseases.
• Subjects with cancer or other life threatening diseases or conditions.
• Pregnant women.
• Subjects who underwent any abdominal surgery.
• Morbid Obesity (BMI > 40).
• Drug abuse or alcoholism.
• Bed-ridden subject.
• Inadequate communication with the subject.
• Subjects under custodial care.
• Participation in any clinical study within the last 30 days.
• Subjects with known cardiovascular and pulmonary diseases.