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CompletedNCT03116880Updated Sep 5, 2018

In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

An observational study in Aortic Aneurysm, Abdominal, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Norwegian University of Science and Technology · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
16
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Aortic Aneurysm, Abdominal

Keywords

  • Aorta, Abdominal/surgery
  • Endovascular Procedures
03

In context

Aortic Aneurysm

663 studies on the registry are indexed under Aortic Aneurysm; 117 are open to participants now.

This study's enrollment of 16 is below the median of 123 across 318 observational studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing endovascular aortic repair at St. Olav Hospital, Trondheim, Norway

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • under 18 years
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • Image registration

    Procedure: Endovascular aortic repair

Interventions

  • ProcedureEndovascular aortic repair

    Endovascular aortic repair

06

What researchers measure

Primary outcomes

  1. Registration accuracy of registration algorithms

    Measure the 3D spread between defined points (registration plate, bony landmarks at vertebrae, vessels if visable)

    Time frame: Immediately

07

Study locations

1 site
  • St. Olavs hospital
    Trondheim, 7030, Norway
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03116880
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Apr 17, 2017
Start date
Apr 19, 2017
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018
Last update
Sep 5, 2018

Study contacts

Øystein Risa
study director · Norwegian University of Science and Technology, Department of Circulation and Medical Imaging

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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