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Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632631
First Posted: July 3, 2012
Last Update Posted: August 13, 2015
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.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose

Ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. Patient-specific image data are incorporated into these simulations, and transformed into a 3D model. This enables the practitioner and his/her team to perform and practice 'real' cases on a virtual patient prior to performing the real procedure on the actual patient. This new technology has been referred to as 'patient-specific' rehearsal, also 'mission' or 'procedure' rehearsal.

Research has already proven that simulated patient-specific rehearsal of a carotid artery stenting procedure may enhance surgical and team performance.

The PROcedure rehearsal software can now also be used to practice patient-specific endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a challenging and complex procedure like EVAR may not only influence device selection based on preoperative planning, but also improve the technical performance of the surgeon/radiologist and the awareness and communication within the entire endovascular team. However, further research is needed to evaluate if this new technology may enhance clinical safety and efficiency, i.e. if patients actually benefit from physicians and team members conducting patient-specific rehearsals of EVAR interventions.


Condition
Infrarenal Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Technical operative metrics [ Time Frame: during EVAR procedure ]
    • C-arm positioning for proximal and distal landing zone
    • Fluoroscopy time
    • Number of angiograms
    • Amount of contrast

  • Errors occurring during EVAR procedure (Imperial College Error Capture record) [ Time Frame: during EVAR procedure ]

Secondary Outcome Measures:
  • Subjective sense of realism of patient-specific rehearsal reported by team members [ Time Frame: immediately after EVAR procedure ]
    Subjective sense of realism of patient-specific rehearsal reported by team members (Measurement: questionnaire)

  • Team satisfaction [ Time Frame: immediately after EVAR procedure ]
    Team satisfaction Measurement: questionnaire

  • Any deviation from initial treatment plan [ Time Frame: immediately after EVAR procedure ]
  • 30 day mortality and morbidity [ Time Frame: within the first 30 days after surgery ]
  • Technical and clinical success rate [ Time Frame: immediately after EVAR procedure ]
    • Successful access to the arterial system using a remote site
    • Successful deployment of the endoluminal graft with secure proximal and distal fixation
    • Absence of either type I or III endoleak
    • Patent endoluminal graft without significant twist, kinks, or obstruction

  • Initial clinical success [ Time Frame: within the first 30 days after surgery ]

    o Successful deployment of the endovascular device at the intended location, without:

    • Death as a result of aneurysm-related treatment
    • Type I or III endoleak
    • Graft infection or thrombosis
    • Aneurysm expansion (diameter > 5mm)
    • Aneurysm rupture
    • Conversion to open repair
    • Graft dilatation (≥ 20% by diameter)
    • Graft migration
    • Failure of device integrity


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: October 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
PROcedure rehearsal
PROcedure rehearsal performed before real EVAR procedure No intervention
No PROcedure rehearsal
no PROcedure rehearsal performed before real EVAR procedure No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an infrarenal aortic aneurysm suitable for endovascular exclusion. The suitability for endovascular repair is based upon the physician's decision.
Criteria

Inclusion Criteria:

-infrarenal aortic aneurysm suitable for endovascular exclusion

Exclusion Criteria:

  • Adult patients who do not have capacity to consent.
  • Previous stent-graft implanted in the abdominal aorta
  Contacts and Locations
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): NCT01632631


Locations
Belgium
Sint - Maarten Hospital, Campus Rooienberg
Duffel, Belgium, 2570
Ghent University Hospital
Ghent, Belgium, 9000
Switzerland
Zurich University Hospital
Zurich, Switzerland, 8091
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Liesbeth Desender University Hospital, Ghent
  More Information

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01632631     History of Changes
Other Study ID Numbers: EC/2012/412
First Submitted: June 28, 2012
First Posted: July 3, 2012
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Ghent:
suitable for endovascular exclusion

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases