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NCT01843322 Clinical Trial

Endoleak Repair Guided by Navigation Technology

Aortic Aneurysm Clinical Trial

Official title:
Endoleak Repair Guided by Navigation Technology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01843322
Other study ID # 2011/720
Secondary ID
Status Completed
Phase N/A
First received April 26, 2013
Last updated March 10, 2017
Start date April 2011
Est. completion date December 2016

Study information
Verified date March 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- detected endoleak

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• endoleak repair procedure (navigation technology )

Locations
Country Name City State
Norway St Olavs Hospital Trondheim

Sponsors (3)
Lead Sponsor Collaborator
Norwegian University of Science and Technology SINTEF Health Research, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary detected leakage number of patients with persistent leakage within 1 hour after intervention
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