Status:

RECRUITING

Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room

Lead Sponsor:

University Ghent

Collaborating Sponsors:

University of Toronto

Conditions:

Patient Safety

Endovascular Procedures

Eligibility:

All Genders

18+ years

Brief Summary

The "OR Black box", an inclusive multiport data capturing system has been developed and successfully used for detailed analysis of laparoscopic surgical procedures. A pilot study has shown that this s...

Eligibility Criteria

Inclusion

  • Patients undergoing elective (planned more than 48 hours) endovascular procedures.
  • Symptomatic aortic-iliac-femoral-popliteal-below the knee atherosclerotic stenotic or occlusive disease (PVI)
  • Endovascular exclusion of thoracic aortic, infrarenal abdominal aortic and/or iliac aneurysm repair (EVAR)

Exclusion

  • No consent of patient
  • No consent of all endovascular team members
  • Emergency procedure (planned \< 48h before)
  • Endovascular procedure not treating atherosclerotic aortic-iliac-femoral-popliteal-below the knee disease or aortic-iliac aneurysm

Key Trial Info

Start Date :

February 19 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT04854278

Start Date

February 19 2019

End Date

December 31 2027

Last Update

December 22 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

UZ Gent

Ghent, Oost-Vlaanderen, Belgium, 9000