Back to resultsEndoleak Repair Guided by Navigation Technology
Primary Purpose
Aortic Aneurysm, Endoleak
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
endoleak repair procedure (navigation technology )
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm focused on measuring Image guided therapy, Endovascular procedures, Angiography, Vascular surgical procedures
Eligibility Criteria
Inclusion Criteria:
- detected endoleak
Exclusion Criteria:
- n/a
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
navigation technology
Arm Description
custom made navigation technology integrated in a Siemens angiography suite for feasibility evaluation in endoleak repair procedure
Outcomes
Primary Outcome Measures
detected leakage
number of patients with persistent leakage
Secondary Outcome Measures
Full Information
NCT ID
NCT01843322
First Posted
April 26, 2013
Last Updated
March 10, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
SINTEF Health Research, St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01843322
Brief Title
Endoleak Repair Guided by Navigation Technology
Official Title
Endoleak Repair Guided by Navigation Technology
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
SINTEF Health Research, St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Endoleak
Keywords
Image guided therapy, Endovascular procedures, Angiography, Vascular surgical procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
navigation technology
Arm Type
Experimental
Arm Description
custom made navigation technology integrated in a Siemens angiography suite for feasibility evaluation in endoleak repair procedure
Intervention Type
Procedure
Intervention Name(s)
endoleak repair procedure (navigation technology )
Primary Outcome Measure Information:
Title
detected leakage
Description
number of patients with persistent leakage
Time Frame
within 1 hour after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
detected endoleak
Exclusion Criteria:
n/a
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter Aadahl, MD Prof
Organizational Affiliation
National Taiwan Normal University
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Endoleak Repair Guided by Navigation Technology
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