Endoleak Repair Guided by Navigation Technology | NCT01843322

Studies
Endoleak Repair Guided by Navigation Technology

NCT01843322

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Mar 14, 2017Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Aortic Aneurysm
Endoleak

Interventions

endoleak repair procedure (navigation technology )

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Apr 26, 2013

First Submission Date that Met QC Criteria

Apr 29, 2013

First Posted Date

Apr 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2017

Last Update Posted Date

Mar 14, 2017Actual

Name	Class
SINTEF Health Research	OTHER
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
endoleak repair procedure (navigation technology )	Procedure		navigation technology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detected leakage	number of patients with persistent leakage	within 1 hour after intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

detected endoleak

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petter Aadahl, MD Prof	National Taiwan Normal University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Olavs Hospital		Trondheim			Norway

Condition Browse Module

MeSH Terms

ID	Term
D001014	Aortic Aneurysm
D057867	Endoleak

Ancestor Terms

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided