First in Man Aer-O-Scope

July 30, 2017 updated by: GI View Ltd.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia
        • Rebro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
single arm patients underwent colonoscopy with aer-o-scope followed by conventional colonoscopy to assess if any mucosal damage occurred with the experimental device.
Biological: screening colonoscopy
performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy
Other Names:
  • colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to traverse the colon using the aer-o-scope
Time Frame: under 60 minutes
a propulsion system using low pressure co2 gas and balloons is used to propel the system through the colon
under 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GI View Ltd.

Investigators

  • Principal Investigator: Boris Vucelic, MD, Chief Gastro, Zagreb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 30, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 30, 2017

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 053 CLD ars 08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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