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NCT Number: NCT07528144

Exoskeleton vs. Standard Lead Apron in EVAR Procedures

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.

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Key information

Conditions

Radiation Exposure to Operator Endovascular Aortic Repair Musculoskeletal Strain Occupational Radiation Exposure

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Hospital No. 2, Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

Location status: Recruiting

Location contact

Paweł Rynio, MD, PhD

CONTACT

[email protected]

914661156

About this study

This is a prospective, randomized, controlled crossover study evaluating an exoskeleton-supported radiation protection system versus standard lead aprons during complex endovascular aortic repair procedures. The study will be conducted at the Department of Vascular Surgery, University Clinical Hospital No. 2 in Szczecin, Pomeranian Medical University.

Two vascular surgeons will participate in the study and perform a total of 60 procedures, including EVAR, IBD-EVAR, and BEVAR. Before each procedure, the type of radiation protection will be randomly assigned: a standard lead apron or an exoskeleton-supported protective system with visor. Each procedure will be performed in full with the assigned protection system, without switching during the intervention.

Operator radiation exposure will be measured in real time using 3 personal dosimeters per operator. Musculoskeletal load will be assessed using shoulder load sensors. After each procedure, operators will complete standardized questionnaires evaluating fatigue and discomfort, including the Borg CR-10 scale, visual analog scale, and Nordic Questionnaire.

The primary objective is to determine whether the exoskeleton-supported protection system reduces operator radiation exposure and musculoskeletal strain during endovascular aortic repair procedures. The results may help improve occupational safety during complex fluoroscopy-guided vascular interventions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: During each procedure

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

  2. Operator radiation exposure

    Time frame: During each procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Paweł Rynio, MD, PhD

CONTACT

[email protected]

914661156

Sponsors and collaborators

Lead sponsor

Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

Other

Registry information

Official study title

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

Acronym: PROTECT-EVAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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