About this trial
The goal of this clinical trial is to learn whether an exoskeleton-supported radiation protection system can reduce radiation exposure and musculoskeletal strain in vascular surgeons during endovascular aortic repair procedures, compared with standard lead aprons. Researchers will compare procedures performed with exoskeleton-supported protection and procedures performed with standard lead aprons. Radiation exposure, physical strain, fatigue, and discomfort will be assessed during and after procedures.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age 35 years or older
written informed consent obtained
vascular surgeon with substantial experience in endovascular procedures
active participation in endovascular aortic repair procedures as a primary operator or assistant
Disqualifiers
refusal or inability to provide informed consent
medical contraindications to the use of standard lead aprons or the exoskeleton-supported radiation protection system
health conditions preventing safe participation in study procedures
Trial design
Crossover
Treatments tested in this trial
Exoskeleton-supported radiation protection system
DeviceAn exoskeleton-supported radiation protection system with visor used by the operator during endovascular aortic repair procedures.
Standard lead apron
DeviceA standard lead apron used by the operator during endovascular aortic repair procedures.
Treatment groups
Trial outcomes
Primary outcomes
Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors.
Operator weight distribution and physical load assessed during endovascular aortic repair procedures using foot-mounted load sensors.
Operator radiation exposure
Operator radiation exposure measured during endovascular aortic repair procedures using real-time personal dosimetry.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.