Production of a Patient-specific Simulator for Endovascular Aneurysm Repair Training
Impact of a Patient-specific Simulation on the Learning Curve of Infra-renal Aneurysm Endovascular Repair
1 other identifier
interventional
55
1 country
1
Brief Summary
The purpose of this study is to produce a patient-specific simulator for endovascular infra-renal aneurysm repair training and than analyze the effect of simulator training on the performance of vascular surgery residents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedMay 8, 2018
July 1, 2016
2 years
February 2, 2015
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fluoroscopy time
The total fluoroscopy time in every surgery will be counted, measured in minutes
2 years - all the surgeries
Secondary Outcomes (6)
Number of participants with Myocardial infarction.
30 days
Number of participants with Renal disfunction
30 days
Death
30 days
Number of participants with Pulmonary complications
30 days
Technical success (Endoprosthesis located in the right position, no endoleak type 1)
30 days
- +1 more secondary outcomes
Study Arms (2)
Group 1
NO INTERVENTION30 patients/5 vascular surgery residents The residents of the last year of vascular surgery will perform the procedure under supervision of a senior surgeon
Group 2
EXPERIMENTAL30 patients/5 vascular surgery residents Patients will have their aneurysm impressed by a 3D printing. The senior vascular surgeon and the residents of this group will be able to practice the procedure in the model as many times as they wish before the surgery. After the training, the EVAR will be performed according to the routine of the hospital.
Interventions
Patients will have their aneurysm impressed by a 3D printing. The senior vascular surgeon and the residents of this group will be able to practice the procedure in the model as many times as they wish before the surgery. After the training, the EVAR will be performed according to the routine of the hospital.
Eligibility Criteria
You may qualify if:
- Patients with infra-renal aneurysm with diameter of 5,5cm or more
- Residents of the last year of vascular surgery at Clinics Hospital of São Paulo University Medical School
You may not qualify if:
- Patients not suitable for endovascular aneurysm repair
- Patients with iliac aneurysm that require iliac bifurcated grafts
- Residents who don't want participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinics Hospital of São Paulo University Medical School
São Paulo, São Paulo, 05403-900, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nelson De Luccia, PhD
Professor of São Paulo University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 26, 2015
Study Start
March 1, 2014
Primary Completion
March 1, 2016
Study Completion
July 1, 2016
Last Updated
May 8, 2018
Record last verified: 2016-07