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In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03116880
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Fluoroscopy is traditionally used for guidance of endovascular aortic repair (EVAR). In order to minimize exposure to radiation and nephrotoxic contrast medium, it is possible to generate a navigation road map by registering the intraoperative images with preoperative computed tomography angiograph (CTA). In modern hybrid operating rooms, several commercial solutions for this exists today (e.g. Siemens Syngo iPilot, Phillips Vesselnavigator). In order to register (fuse) the preoperative and intraoperative imaging to each other, a registration algorithm has to be applied. Sufficient accuracy of this algorithm is crucial, for if it fails the road map cannot be used for intraoperative navigation. The purpose of this study is therefore to evaluate two different 3D registration algorithms with regard to registration accuracy.

Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal Procedure: Endovascular aortic repair

Detailed Description:

Two different registration algorithms will be tested:

  1. registration algorithm - centerline registration algorithm (Sintef, Trondheim) A catheter equipped with a position sensor records the travelled path of the instrument, which is assumed to be close to the centerline of the aorta. From the preoperative computer tomography scan (CT) the aorta is segmented and vessel centerline is extracted. The centerline from the position sensor recordings is registered to the extracted centerline of the preoperative CT.
  2. 3D-3D registration algorithm (Syngo iPilot, Siemens Medical Solutions, Munich). Intraoperative cone-beam-CT (CBCT) is registered to the preoperative CT

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: In Vivo Evaluation of Image Registration Techniques During Endovascular Repair
Actual Study Start Date : April 19, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Group/Cohort Intervention/treatment
Image registration Procedure: Endovascular aortic repair
Endovascular aortic repair




Primary Outcome Measures :
  1. Registration accuracy of registration algorithms [ Time Frame: Immediately ]
    Measure the 3D spread between defined points (registration plate, bony landmarks at vertebrae, vessels if visable)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing endovascular aortic repair at St. Olav Hospital, Trondheim, Norway
Criteria

Inclusion Criteria:

  • infrarenal or juxtarenal abdominal aortic aneurysm
  • undergoing EVAR
  • informed consent

Exclusion Criteria:

  • under 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116880


Locations
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Norway
St. Olavs hospital
Trondheim, Norway, 7030
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Øystein Risa Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03116880    
Other Study ID Numbers: 2016/533
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Aorta, Abdominal/surgery
Endovascular Procedures
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases