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Search / Trial NCT04854278

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

Launched by UNIVERSITY GHENT · Apr 16, 2021

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of a system called the "OR Black Box" in the hybrid operating room, which is a special area where doctors perform advanced procedures on blood vessels. This system collects and analyzes important information during surgeries to help identify and prevent mistakes, ultimately aiming to improve patient safety. The research focuses on understanding how factors like teamwork, the surgeon's leadership style, and the operating environment influence the success of the surgery and any errors that may occur.

If you or a family member are between the ages of 65 and 74 and are scheduled for a planned endovascular procedure (a type of surgery to treat problems in blood vessels), you might be eligible to participate in this trial. Participants will be closely monitored during their surgery, and the information gathered will help improve future procedures. It’s important to know that only patients who give consent, along with the consent of the entire surgical team, can take part, and emergency procedures are not included in this study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About University Ghent

University Ghent is a prestigious Belgian research institution renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a multidisciplinary approach, the university fosters collaboration among leading experts in various fields, ensuring rigorous study design and ethical standards. University Ghent is dedicated to exploring new therapeutic modalities and enhancing healthcare outcomes, making significant contributions to both local and global health landscapes. Its state-of-the-art facilities and emphasis on research excellence position it as a pivotal sponsor in the realm of clinical research.

Locations

Ghent, Oost Vlaanderen, Belgium

Patients applied

0 patients applied

Trial Officials

Isabelle Van Herzeele, MD, PhD

Principal Investigator

University Ghent

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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