NCT01843322

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

5.7 years

First QC Date

April 26, 2013

Last Update Submit

March 10, 2017

Conditions

Aortic AneurysmEndoleak

Keywords

Image guided therapyEndovascular proceduresAngiographyVascular surgical procedures

Outcome Measures

Primary Outcomes (1)

  • detected leakage

    number of patients with persistent leakage

    within 1 hour after intervention

Study Arms (1)

navigation technology

EXPERIMENTAL

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

Procedure: endoleak repair procedure (navigation technology )

Interventions

endoleak repair procedure (navigation technology )PROCEDURE
navigation technology

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • detected endoleak

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Aortic AneurysmEndoleak

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPostoperative HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Petter Aadahl, MD Prof

    National Taiwan Normal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

April 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

NO(1)