First in Man Aer-O-Scope

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02102412
• Other study ID #: 053 CLD ars 08
• Status: Terminated
• Phase: Phase 1
• First received: March 30, 2014
• Last updated: July 30, 2017
• Start date: February 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2014
• Source: GI View Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Screening Colonoscopy for Low Risk Subjects

Intervention

Biological:
• screening colonoscopy
performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy

Locations

Country	Name	City	State
Croatia	Rebro Hospital	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
GI View Ltd.

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to traverse the colon using the aer-o-scope	a propulsion system using low pressure co2 gas and balloons is used to propel the system through the colon	under 60 minutes