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CompletedNCT01843322Updated Mar 14, 2017

Endoleak Repair Guided by Navigation Technology

An interventional study of endoleak repair procedure (navigation technology ) in Aortic Aneurysm and Endoleak, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-14.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Apr 2011, registered Apr 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Aortic Aneurysm
  • Endoleak

Keywords

  • Image guided therapy
  • Endovascular procedures
  • Angiography
  • Vascular surgical procedures
03

In context

Aortic Aneurysm

222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.

This study's enrollment of 27 is below the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • detected endoleak

Exclusion criteria

Exclusion Criteria:

  • n/a
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    navigation technology

    custom made navigation technology integrated in a Siemens angiography suite for feasibility evaluation in endoleak repair procedure

    Procedure: endoleak repair procedure (navigation technology )

Interventions

  • Procedureendoleak repair procedure (navigation technology )
06

What researchers measure

Primary outcomes

  1. detected leakage

    number of patients with persistent leakage

    Time frame: within 1 hour after intervention

07

Study locations

1 site
  • St Olavs Hospital
    Trondheim, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01843322
Collaborators
SINTEF Health Research, St. Olavs Hospital
Responsible party
Sponsor
First posted
Apr 30, 2013
Start date
Apr 2011
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Mar 14, 2017

Study contacts

Petter Aadahl, MD Prof
study director · National Taiwan Normal University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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