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

NCT ID: NCT01632631

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infrarenal Aortic Aneurysm

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

suitable for endovascular exclusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PROcedure rehearsal

PROcedure rehearsal performed before real EVAR procedure No intervention

No interventions assigned to this group

No PROcedure rehearsal

no PROcedure rehearsal performed before real EVAR procedure No intervention

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Liesbeth Desender

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sint - Maarten Hospital, Campus Rooienberg

Duffel, , Belgium

Site Status

Ghent University Hospital

Ghent, , Belgium

Site Status

Zurich University Hospital

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Desender L, Van Herzeele I, Lachat M, Duchateau J, Bicknell C, Teijink J, Heyligers J, Vermassen F; PAVLOV Study Group. A Multicentre Trial of Patient specific Rehearsal Prior to EVAR: Impact on Procedural Planning and Team Performance. Eur J Vasc Endovasc Surg. 2017 Mar;53(3):354-361. doi: 10.1016/j.ejvs.2016.12.018. Epub 2017 Jan 20.

Reference Type DERIVED
PMID: 28117241 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EC/2012/412

Identifier Type: -

Identifier Source: org_study_id