Abdominal Aortic AneurysmNCT00264862
DynaCT Imaging in EVAR: Comparing Clinical Benefit of DynaCT to Multidetector CT as the Current Gold Standard.
A study testing DynaCT in people with Abdominal Aortic Aneurysm, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of this study is to evaluate a new way to create CT-like images during intra-operative procedures. We want to prove that the quality and information received from DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- DynaCT
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2005to Mar 2007
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age over 65,
- Satisfactory renal function
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of DynaCT in Endovascular Treatment of Abdominal Aortic Aneurysm. Evaluation of Image Quality.
The aim of this study is to evaluate a new way to create CT-like images during intra-operative procedures. We want to prove that the quality and information received from DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm.
Read the detailed description
The study will compare images from the new modality (DynaCT) with the present modality (Multi detectorCT). We make three different set of images from each modality.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- DynaCT
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynaCTProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence og clinical benefit of new imaging functionality.
Measured: 3 days (pluss or minus 3 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startDec 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Kari R Eide, MS, Principal investigator, NTNU/St.Olavs HospitalOlav Haraldseth, PhD MD, Study chair, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264862
- Sponsor's protocol ID
- FOR2008_1
- Status last verified
- Feb 2014
- First submitted
- 12 Dec 2005
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Eide KR, Odegard A, Myhre HO, Lydersen S, Hatlinghus S, Haraldseth O. DynaCT during EVAR--a comparison with multidetector CT. Eur J Vasc Endovasc Surg. 2009 Jan;37(1):23-30. doi: 10.1016/j.ejvs.2008.09.017. Epub 2008 Nov 17.
PubMed 19010697
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of DynaCT in Endovascular Treatment of Abdominal Aortic Aneurysm. Evaluation of Image Quality.
- ClinicalTrials.gov ID
- NCT00264862
- Acronym / sponsor ID
- FOR2008_1
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Dec 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 13 Dec 2005 (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 aim of this study is to evaluate a new way to create CT-like images during intra-operative procedures. We want to prove that the quality and information received from DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm.
Detailed description
The study will compare images from the new modality (DynaCT) with the present modality (Multi detectorCT). We make three different set of images from each modality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age over 65,
- Satisfactory renal function
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DynaCT | Procedure or surgery | – |
Primary outcome
Evidence og clinical benefit of new imaging functionality.
Time frame: 3 days (pluss or minus 3 days).
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 28 Feb 2014.
- Results publication: PubMed 19010697Eide KR, Odegard A, Myhre HO, Lydersen S, Hatlinghus S, Haraldseth O. DynaCT during EVAR--a comparison with multidetector CT. Eur J Vasc Endovasc Surg. 2009 Jan;37(1):23-30. doi: 10.1016/j.ejvs.2008.09.017. Epub 2008 Nov 17.
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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.
Kari R Eide, MS principal investigator
NTNU/St.Olavs Hospital
Olav Haraldseth, PhD MD study chair
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 DynaCT in people with Abdominal Aortic Aneurysm, 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 2 inclusion and 0 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 28 Feb 2014. 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?
Evidence og clinical benefit of new imaging functionality. (time frame: 3 days (pluss or minus 3 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264862, which also lists 1 linked publication.
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 28 Feb 2014.