First in Man Aer-O-Scope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-12-31

Brief Summary

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

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Detailed Description

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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

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Screening Colonoscopy for Low Risk Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

screening colonoscopy

Intervention Type BIOLOGICAL

performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy

Interventions

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screening colonoscopy

performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy

Intervention Type BIOLOGICAL

Other Intervention Names

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colonoscopy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes