Actively Recruiting
Radiation Exposure and Operator Musculoskeletal Strain in Endovascular Aortic Repair: Comparing Exoskeleton-Supported vs. Standard Lead Aprons
Led by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM · Updated on 2026-04-14
2
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if using an exoskeleton-supported radiation protection system can lower radiation exposure and reduce muscle strain for vascular surgeons during complex endovascular aortic repair procedures. The study will compare this new system with the standard lead aprons currently used, focusing on radiation exposure, physical strain, fatigue, and discomfort experienced by the surgeons. The study is a prospective, randomized, controlled crossover trial involving two vascular surgeons performing 60 procedures such as EVAR, IBD-EVAR, and BEVAR. Before each procedure, surgeons will be randomly assigned to wear either the exoskeleton-supported protection system with a visor or the standard lead apron. Each procedure will be completed fully using the assigned protection without switching. During the procedures, real-time radiation exposure will be recorded using personal dosimeters, and musculoskeletal strain will be measured with shoulder load sensors. After each procedure, surgeons will fill out questionnaires to assess fatigue and discomfort. The study will evaluate whether the exoskeleton system offers benefits in reducing radiation and strain to improve safety during these vascular interventions.
CONDITIONS
Brief Title
Exoskeleton vs. Standard Lead Apron in EVAR Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 primary operator or assistant
- High procedural volume in endovascular interventions
You will not qualify if you...
- Refusal or inability to provide informed consent
- Medical contraindications to using standard lead aprons or the exoskeleton-supported radiation protection system
- Health conditions preventing safe participation in study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of study procedures, up to completion of 60 procedures
Participants undergo endovascular aortic repair procedures using either the exoskeleton-supported radiation protection system with visor or the standard lead apron, with the type of protection randomly assigned before each procedure.
Multiple procedure visits as assigned by randomization
Trial Site Locations
Total: 1 location
1
University Clinical Hospital No. 2, Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, Poland, 70-111
Actively Recruiting
Research Team
P
Paweł Rynio, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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