Endoleak Repair Guided by Navigation Technology

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT01843322
• Collaborator: SINTEF Health Research (Other), St. Olavs Hospital (Other)
• Enrollment: 27
• Location: 1
• Arm: 1
• Actual Duration (Months): 68
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm; Endoleak	Procedure: endoleak repair procedure (navigation technology )	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endoleak Repair Guided by Navigation Technology
• Actual Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 )

Outcome Measures

Primary Outcome Measures

1. detected leakage [within 1 hour after intervention]

   number of patients with persistent leakage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• detected endoleak

Exclusion Criteria:

• n/a

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Olavs Hospital	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• SINTEF Health Research
• St. Olavs Hospital

Investigators

• Study Director: Petter Aadahl, MD Prof, National Taiwan Normal University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT01843322
• Other Study ID Numbers: 2011/720
• First Posted: Apr 30, 2013
• Last Update Posted: Mar 14, 2017
• Last Verified: Mar 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Image guided therapy; Endovascular procedures; Angiography; Vascular surgical procedures
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Endoleak

Study Results

No Results Posted as of Mar 14, 2017