RecruitingNot ApplicableNCT07528144

Exoskeleton vs. Standard Lead Apron in EVAR Procedures

Radiation Exposure and Operator Musculoskeletal Strain in Endovascular Aortic Repair: a Randomized Trial of Exoskeleton vs. Standard Aprons


Sponsor

Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

Enrollment

2 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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

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Interventions

DEVICEExoskeleton-supported radiation protection system

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

DEVICEStandard lead apron

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


Locations(1)

University Clinical Hospital No. 2, Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, Poland

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NCT07528144


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