Exoskeleton vs. Standard Lead Apron in EVAR Procedures (NCT07528144) | Clinical Trial Compass
RecruitingNot Applicable
Exoskeleton vs. Standard Lead Apron in EVAR Procedures
Poland2 participantsStarted 2025-11-03
Plain-language summary
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.
Who can participate
Age range
35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors.
Timeframe: During each procedure
2
Operator radiation exposure
Timeframe: During each procedure
Trial details
NCT IDNCT07528144
SponsorSamodzielny Publiczny Szpital Kliniczny nr 2 PUM