First in Man Aer-O-Scope

Phase 1

Terminated

• Conditions: Screening Colonoscopy for Low Risk Subjects
• Interventions: Biological: screening colonoscopy

• Registration Number: NCT02102412
• Lead Sponsor: GI View Ltd.

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)

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-30
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-02
• Last Update Submitted: 2017-07-30
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	screening colonoscopy	single arm patients underwent colonoscopy with aer-o-scope followed by conventional colonoscopy to assess if any mucosal damage occurred with the experimental device.

Primary Outcome Measures

Name	Time	Method
Ability to traverse the colon using the aer-o-scope	under 60 minutes	a propulsion system using low pressure co2 gas and balloons is used to propel the system through the colon

Trial Locations

Locations (1)

Rebro Hospital; 🇭🇷 Zagreb, Croatia