Screening Colonoscopy for Low Risk Subjects
Conditions
Keywords
crc, colonoscopy, colon cancer
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)
Interventions
BIOLOGICALscreening colonoscopy
performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy
Sponsors
GI View Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Croatia
Outcome results
None listed