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Clinical Trials in Poland / NCT07528144
Recruiting Not applicable

Exoskeleton vs. Standard Lead Apron in EVAR Procedures

NCT07528144 · tracked via the Priya Life Science Poland tracker
Sponsor
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Phase
Not applicable
Started
2025-11-03
Last updated
2026-08-13

Condition(s) studied

Radiation Exposure to OperatorEndovascular Aortic RepairMusculoskeletal StrainOccupational Radiation Exposure

Investigational drug(s) / intervention(s)

Exoskeleton-supported radiation protection systemStandard lead apron

Exoskeleton-supported radiation protection system: An exoskeleton-supported radiation protection system with visor used by the operator during endovascular aortic repair procedures.

Standard lead apron: A standard lead apron used by the operator during endovascular aortic repair procedures.

Study 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.

Eligibility

Sex
ALL
Min age
35 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors. — During each procedure
    Operator weight distribution and physical load assessed during endovascular aortic repair procedures using foot-mounted load sensors.
  • Operator radiation exposure — During each procedure
    Operator radiation exposure measured during endovascular aortic repair procedures using real-time personal dosimetry.

Trial sites (1)

FacilityCityRegionStatus
University Clinical Hospital No. 2, Pomeranian Medical University Szczecin West Pomeranian Voivodeship Recruiting

More Samodzielny Publiczny Szpital Kliniczny nr 2 PUM trials in Poland

Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07528144 on ClinicalTrials.gov ↗ ← All trials in Poland