Exoskeleton-supported protection versus lead apron during endovascular aortic repair
Radiation Exposure and Operator Musculoskeletal Strain in Endovascular Aortic Repair: a Randomized Trial of Exoskeleton vs. Standard Aprons
This study will test whether using an exoskeleton-supported radiation protection system can lower radiation exposure and reduce muscle strain for vascular surgeons doing complex endovascular aortic repairs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Samodzielny Publiczny Szpital Kliniczny nr 2 PUM Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Szczecin, West Pomeranian Voivodeship) |
| Trial ID | NCT07528144 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled crossover trial conducted at the Department of Vascular Surgery, University Clinical Hospital No. 2 in Szczecin, Poland. Two experienced vascular surgeons will perform a total of 60 EVAR, BEVAR, and IBD-EVAR procedures, with each procedure randomly assigned to use either a standard lead apron or an exoskeleton-supported protection system with visor. Operator radiation exposure will be recorded in real time with personal dosimeters, and shoulder load will be measured with sensors; operators will also complete standardized fatigue and discomfort questionnaires after each case. No switching of protection systems will occur during individual procedures so that each intervention is completed under the assigned protection method.
Who should consider this trial
Good fit: Ideal participants are experienced vascular surgeons age 35 or older who regularly perform endovascular aortic repair procedures and can provide informed consent and safely use both standard lead aprons and the exoskeleton system.
Not a fit: Surgeons who do not perform complex endovascular aortic repairs, who cannot safely wear the exoskeleton or lead apron, or who have health contraindications to participation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the exoskeleton-supported system could meaningfully reduce surgeons' radiation exposure and musculoskeletal strain during complex fluoroscopic vascular procedures, improving occupational safety and comfort.
How similar studies have performed: Small feasibility studies of wearable exoskeletons in surgical and interventional settings have shown reduced musculoskeletal load and fatigue, but combining exoskeleton support with radiation-protective visors is relatively novel and has limited comparative data on radiation dose reduction.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Szczecin, West Pomeranian Voivodeship
- University Clinical Hospital No. 2, Pomeranian Medical University — Szczecin, West Pomeranian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Paweł Rynio, MD, PhD
- Email: p.rynio@spsk2.szczecin.pl
- Phone: 914661156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.