Exoskeleton-supported protection versus lead apron during endovascular aortic repair
Official title: Radiation Exposure and Operator Musculoskeletal Strain in Endovascular Aortic Repair: a Randomized Trial of Exoskeleton vs. Standard Aprons
Run by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM · NCT07528144 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 35 Years and up |
| Sex | All |
| Enrollment | 2 (estimated) |
| Sponsor | Samodzielny Publiczny Szpital Kliniczny nr 2 PUM Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Szczecin, West Pomeranian Voivodeship) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | June 17, 2027 |
| Study ends | June 17, 2027 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07528144 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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@usk2.szczecin.pl
- Phone: 914661156
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Reducing radiation exposure in the heart cath lab using RAMPART
This study will test whether the RAMPART device reduces radiation exposure for doctors and nurses during coronary catheter procedures and allows them to wear lighter or no lead protection.
-
Evaluating a new tool for branched endovascular aortic repair
This study is testing a new stent design for aortic repair to see if it works well and is easy to use for patients undergoing this treatment.
-
Evaluating a new device for aortic repair
This study is testing a new custom-made device for repairing certain aortic problems to see if it works well and is easy to use for patients needing this treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.