Exoskeleton vs. Standard Lead Apron in EVAR Procedures

NCT07528144 | Recruiting

• 1 other identifier: KB-006/76/2025
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

EVAR; BEVAR; IBD-EVAR; Exoskeleton; Lead Apron; Occupational Safety; Ionizing Radiation; Vascular Surgeon; Ergonomics

Outcome Measures

Primary Outcomes (2)

• 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.

  During each procedure

• Operator radiation exposure

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

  During each procedure

Study Arms (2)

Exoskeleton-Supported Protection System

EXPERIMENTAL

Endovascular aortic repair procedures performed with an exoskeleton-supported radiation protection system with visor.

Device: Exoskeleton-supported radiation protection system

Standard Lead Apron

ACTIVE COMPARATOR

Endovascular aortic repair procedures performed with standard lead apron radiation protection.

Device: Standard lead apron

Interventions

Standard lead apron DEVICE

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

Standard Lead Apron

Exoskeleton-supported radiation protection system DEVICE

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

Exoskeleton-Supported Protection System

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samodzielny Publiczny Szpital Kliniczny nr 2 PUM: lead

Study Sites (1)

University Clinical Hospital No. 2, Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

RECRUITING

Central Study Contacts

Paweł Rynio, MD, PhD

CONTACT

914661156; p.rynio@spsk2.szczecin.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): June 17, 2027
• Study Completion (Estimated): June 17, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)