NCT07528144

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Exoskeleton-supported radiation protection system	An exoskeleton-supported radiation protection system with visor used by the operator during endovascular aortic repair procedures.
DEVICE	Standard lead apron	A standard lead apron used by the operator during endovascular aortic repair procedures.

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-06-17
• Completion: 2027-06-17
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Poland