Exoskeleton vs. Standard Lead Apron in EVAR Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exoskeleton-supported radiation protection system, Standard lead apron.
- Who it may be relevant to
- Registry conditions: Radiation Exposure to Operator, Endovascular Aortic Repair, Musculoskeletal Strain, Occupational Radiation Exposure. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Radiation Exposure and Operator Musculoskeletal Strain in Endovascular Aortic Repair: a Randomized Trial of Exoskeleton vs. Standard Aprons
Overview
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.
Detailed description
This is a prospective, randomized, controlled crossover study evaluating an exoskeleton-supported radiation protection system versus standard lead aprons during complex endovascular aortic repair procedures. The study will be conducted at the Department of Vascular Surgery, University Clinical Hospital No. 2 in Szczecin, Pomeranian Medical University.
Two vascular surgeons will participate in the study and perform a total of 60 procedures, including EVAR, IBD-EVAR, and BEVAR. Before each procedure, the type of radiation protection will be randomly assigned: a standard lead apron or an exoskeleton-supported protective system with visor. Each procedure will be performed in full with the assigned protection system, without switching during the intervention.
Operator radiation exposure will be measured in real time using 3 personal dosimeters per operator. Musculoskeletal load will be assessed using shoulder load sensors. After each procedure, operators will complete standardized questionnaires evaluating fatigue and discomfort, including the Borg CR-10 scale, visual analog scale, and Nordic Questionnaire.
The primary objective is to determine whether the exoskeleton-supported protection system reduces operator radiation exposure and musculoskeletal strain during endovascular aortic repair procedures. The results may help improve occupational safety during complex fluoroscopy-guided vascular interventions.
Interventions
- Device Exoskeleton-supported radiation protection system
An exoskeleton-supported radiation protection system with visor used by the operator during endovascular aortic repair procedures. - Device Standard lead apron
A standard lead apron used by the operator during endovascular aortic repair procedures.
Primary outcome measures
- Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors. [Time frame: During each procedure]
- Operator radiation exposure [Time frame: During each procedure]
Eligibility criteria
Inclusion criteria
- 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
- high procedural volume in endovascular interventions
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
Poland · 1 center
- University Clinical Hospital No. 2, Pomeranian Medical University — Szczecin
Identifiers
NCT: NCT07528144 · KB-006/76/2025