Aortic AneurysmNCT01843322
Endoleak Repair Guided by Navigation Technology
A study testing endoleak repair procedure (navigation technology ) in people with Aortic Aneurysm and Endoleak, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The study is aimed at investigating whether repair of endoleak type II can be improved by adding navigation technology. Can this technology increase precision by guiding the needle that punctures through the skin as used during the repair procedure? Can the procedure logistics be improved by using navigation… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aortic Aneurysm, Endoleak
- What is being tested?
- endoleak repair procedure (navigation technology )
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Dec 2016
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- detected endoleak
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
The study is aimed at investigating whether repair of endoleak type II can be improved by adding navigation technology. Can this technology increase precision by guiding the needle that punctures through the skin as used during the repair procedure? Can the procedure logistics be improved by using navigation technology instead of computed tomography (CT) guidance of the needle puncture? Parameters logged during the procedure:
- was the needle placement successful?
- number of needle punctures?
- time used on guidance procedure
- X-ray exposure dose
- Conditions
- Aortic Aneurysm, Endoleak
- Being tested
- endoleak repair procedure (navigation technology )
- Keywords
- Image guided therapy, Endovascular procedures, Angiography, Vascular surgical procedures
- Medical subject headings
- Aortic Aneurysm, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoleak repair procedure (navigation technology )Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| navigation technology | Experimental | custom made navigation technology integrated in a Siemens angiography suite for feasibility evaluation in endoleak repair procedure Receives: Procedure: endoleak repair procedure (navigation technology ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
detected leakage
number of patients with persistent leakage
Measured: within 1 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startApr 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- SINTEF Health Research, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Petter Aadahl, MD Prof, Study director, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843322
- Sponsor's protocol ID
- 2011/720
- Status last verified
- Mar 2017
- First submitted
- 26 Apr 2013
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoleak Repair Guided by Navigation Technology
- ClinicalTrials.gov ID
- NCT01843322
- Acronym / sponsor ID
- 2011/720
- Conditions
- Aortic Aneurysm, Endoleak
- Keywords
- Image guided therapy, Endovascular procedures, Angiography, Vascular surgical procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- SINTEF Health Research, St. Olavs Hospital
- Study start
- Apr 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Apr 2013 (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.
The study is aimed at investigating whether repair of endoleak type II can be improved by adding navigation technology. Can this technology increase precision by guiding the needle that punctures through the skin as used during the repair procedure? Can the procedure logistics be improved by using navigation technology instead of computed tomography (CT) guidance of the needle puncture? Parameters logged during the procedure:
- was the needle placement successful?
- number of needle punctures?
- time used on guidance procedure
- X-ray exposure dose
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| navigation technology | Experimental | Procedure: endoleak repair procedure (navigation technology )custom made navigation technology integrated in a Siemens angiography suite for feasibility evaluation in endoleak repair procedure |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- detected endoleak
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| endoleak repair procedure (navigation technology ) | Procedure or surgery | navigation technology |
Primary outcome
detected leakage
Time frame: within 1 hour after intervention
number of patients with persistent leakage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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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.
Petter Aadahl, MD Prof study director
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoleak repair procedure (navigation technology ) in people with Aortic Aneurysm and Endoleak, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Mar 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 Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
detected leakage (time frame: within 1 hour after intervention). 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 14 Mar 2017.