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Production of a Patient-specific Simulator for Endovascular Aneurysm Repair Training

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: NCT02372214
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Aneurysm Procedure: Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of a Patient-specific Simulation on the Learning Curve of Infra-renal Aneurysm Endovascular Repair
Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
No Intervention: Group 1
30 patients/5 vascular surgery residents The residents of the last year of vascular surgery will perform the procedure under supervision of a senior surgeon
Experimental: Group 2
30 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.
Procedure: Training
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.




Primary Outcome Measures :
  1. Fluoroscopy time [ Time Frame: 2 years - all the surgeries ]
    The total fluoroscopy time in every surgery will be counted, measured in minutes


Secondary Outcome Measures :
  1. Number of participants with Myocardial infarction. [ Time Frame: 30 days ]
    The Number of participants with Myocardial infarction (CKMB or Troponin positive curve or change in ECG) within 30 days of the surgery.

  2. Number of participants with Renal disfunction [ Time Frame: 30 days ]
    Number of participants with renal disfunction (necessity of hemodialysis or enhance of creatinine level) within 30 days of the surgery.

  3. Death [ Time Frame: 30 days ]
  4. Number of participants with Pulmonary complications [ Time Frame: 30 days ]
    Number of participants with Pulmonary complications (Pneumonia, Pulmonary congestion) within 30 days of the surgery.

  5. Technical success (Endoprosthesis located in the right position, no endoleak type 1) [ Time Frame: 30 days ]
    Endoprosthesis located in the right position, no endoleak type 1

  6. Contrast volume in each surgery [ Time Frame: 2 years ]
    The volume of contrast used in all the surgeries will be measured in milliliters during the period of the study.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients not suitable for endovascular aneurysm repair
  • Patients with iliac aneurysm that require iliac bifurcated grafts
  • Residents who don't want participate

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): NCT02372214


Locations
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Brazil
Clinics Hospital of São Paulo University Medical School
São Paulo, SP, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Nelson De Luccia, PhD Professor of São Paulo University Medical School
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02372214    
Other Study ID Numbers: 3Daneurysm
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Sao Paulo General Hospital:
Endovascular Procedures
3D printing
Simulation
Training
Learning curve
Education
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases