Exoskeleton vs. Standard Lead Apron in EVAR Procedures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorSamodzielny Publiczny Szpital Kliniczny nr 2 PUM

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Exoskeleton-supported radiation protection system

    Device

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

  • Standard lead apron

    Device

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

Treatment groups

2 Participants
are divided into 2 treatment groups
Group A: Exoskeleton-Supported Protection SystemExperimental treatment 1 intervention
Group B: Standard Lead ApronActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors.

Operator weight distribution and physical load assessed during endovascular aortic repair procedures using foot-mounted load sensors.

Time frame
During each procedure
2

Operator radiation exposure

Operator radiation exposure measured during endovascular aortic repair procedures using real-time personal dosimetry.

Time frame
During each procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.