Endoleak Repair Guided by Navigation Technology

NCT ID: NCT01843322

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Aortic Aneurysm Endoleak

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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navigation technology

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

Group Type EXPERIMENTAL

endoleak repair procedure (navigation technology )

Intervention Type PROCEDURE

Interventions

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endoleak repair procedure (navigation technology )

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* detected endoleak

Exclusion Criteria

* n/a
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SINTEF Health Research

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petter Aadahl, MD Prof

Role: STUDY_DIRECTOR

National Taiwan Normal University

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2011/720

Identifier Type: -

Identifier Source: org_study_id

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