Screening Colonoscopy for Low Risk SubjectsPhase 1NCT02102412
First in Man Aer-O-Scope
A Phase 1 study testing screening colonoscopy in people with Screening Colonoscopy for Low Risk Subjects, run by GI View Ltd. at 1 site in Croatia.
Trial summary
A single center study intended to evaluate the Aer-O-Scope Colonoscope System. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening Colonoscopy for Low Risk Subjects
- What is being tested?
- screening colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCroatia
- Study dates
- Feb 2005to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers between 18 and 65 years of age.
- Sign informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Advancement of device towards the ceacum and retraction
- Visualization of the colon mucosa by the traveling imaging device
- Procedure duration
- Handling and operation (assessment by operator)
- Being tested
- screening colonoscopy
- Keywords
- crc, colonoscopy, colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening colonoscopyBiological
Also called colonoscopy
performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | single arm patients underwent colonoscopy with aer-o-scope followed by conventional colonoscopy to assess if any mucosal damage occurred with the experimental device. Receives: Biological: screening colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: under 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startFeb 2005
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Changes made to device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening Colonoscopy for Low Risk SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI View Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Vucelic, MD, Principal investigator, Chief Gastro, Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102412
- Sponsor's protocol ID
- 053 CLD ars 08
- Status last verified
- Mar 2014
- First submitted
- 30 Mar 2014
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study to Evaluate the Safety & Performance of the Aer-O-Scope for Traveling Through the Colon in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02102412
- Acronym / sponsor ID
- 053 CLD ars 08
- Keywords
- crc, colonoscopy, colon cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes made to device.
- Enrolment
- 101 participants (actual)
- Lead sponsor
- GI View Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Advancement of device towards the ceacum and retraction
- Visualization of the colon mucosa by the traveling imaging device
- Procedure duration
- Handling and operation (assessment by operator)
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: screening colonoscopysingle arm patients underwent colonoscopy with aer-o-scope followed by conventional colonoscopy to assess if any mucosal damage occurred with the experimental device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers between 18 and 65 years of age.
- Sign informed consent.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening colonoscopyAlso: colonoscopyperformance of a colonoscopy with the experimental device followed by complete conventional colonoscopy | Biological | single arm |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Changes made to device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Vucelic, MD principal investigator
Chief Gastro, Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing screening colonoscopy in people with Screening Colonoscopy for Low Risk Subjects, run by GI View Ltd. at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Changes made to device.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to traverse the colon using the aer-o-scope (time frame: under 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017; AzTrials last refreshed its copy on 28 Oct 2026.