Exoskeleton vs. Standard Lead Apron in EVAR Procedures (PROTECT-EVAR)

April 7, 2026 updated by: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-111
        • Recruiting
        • University Clinical Hospital No. 2, Pomeranian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exoskeleton-Supported Protection System
Endovascular aortic repair procedures performed with an exoskeleton-supported radiation protection system with visor.
Device: Exoskeleton-supported radiation protection system
An exoskeleton-supported radiation protection system with visor used by the operator during endovascular aortic repair procedures.
Active Comparator: Standard Lead Apron
Endovascular aortic repair procedures performed with standard lead apron radiation protection.
Device: Standard lead apron
A standard lead apron used by the operator during endovascular aortic repair procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During each procedure
Operator radiation exposure
Time Frame: During each procedure
Operator radiation exposure measured during endovascular aortic repair procedures using real-time personal dosimetry.
During each procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

June 17, 2027

Study Completion (Estimated)

June 17, 2027

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KB-006/76/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because of the small sample size and the risk of participant identification.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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