- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146639
DynaCT in Preoperative Imaging Before Insertion of Stentgraft (DynaCT)
January 16, 2017 updated by: Norwegian University of Science and Technology
Usefulness of DynaCT Compared to Multidetector CT as Preoperative Imaging Before Insertion of Aortic Stentgraft.
Endovascular therapy of Aortic Aneurysms depends on good imaging facilities.
A relatively new kind of x-ray equipment makes it possible to create computer tomography (CT) - like slice images in the operating room.
The purpose of this study is to verify the clinical usefulness of DynaCT in a preoperative setting.
To do so we compare aortic measurements in DynaCT to the same measurements in ordinary CT-images which are regarded the gold standard.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway
- St Olavs Hospital, Operating Room of the Future.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Not inserted stent graft before.
- Patiens over 60 Years old.
- Able to give informed consent.
Exclusion Criteria: Not
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MDCT and additional DynaCT
|
One extra set of images with DynaCT including one extra injection of contrast medium.
One extra set of images with DynaCT including one extra injection of 50 ml contrast medium.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Verify clinical usefulness of DynaCT images in preoperative imaging.
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
June 16, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (Estimate)
June 17, 2010
Study Record Updates
Last Update Posted (Estimate)
January 18, 2017
Last Update Submitted That Met QC Criteria
January 16, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- rek 4.2008.802
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.