Radiation Exposure to OperatorPROTECT-EVARNCT07528144
Exoskeleton vs. Standard Lead Apron in EVAR Procedures
A study testing Exoskeleton-supported radiation protection system and Standard lead apron in people with Radiation Exposure to Operator and Endovascular Aortic Repair, run by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Exposure to Operator, Endovascular Aortic Repair, Musculoskeletal Strain
- What is being tested?
- Exoskeleton-supported radiation protection system and Standard lead apron
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 sitePoland
- Study dates
- 3 Nov 2025to 17 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Hospital No. 2, Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, 70-111
Paweł Rynio, MD, PhD, 914661156, p.rynio@usk2.szczecin.pl
About this study
Official title: 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.
Read the 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
- Being tested
- Exoskeleton-supported radiation protection system, Standard lead apron
- Keywords
- EVAR, BEVAR, IBD-EVAR, Exoskeleton, Lead Apron, Occupational Safety, Ionizing Radiation, Vascular Surgeon, Ergonomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton-supported radiation protection systemDevice
An exoskeleton-supported radiation protection system with visor used by the operator during endovascular aortic repair procedures.
Standard lead apronDevice
A standard lead apron used by the operator during endovascular aortic repair procedures.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton-Supported Protection System | Experimental | Endovascular aortic repair procedures performed with an exoskeleton-supported radiation protection system with visor. Receives: Device: Exoskeleton-supported radiation protection system |
| Standard Lead Apron | Active comparator | Endovascular aortic repair procedures performed with standard lead apron radiation protection. Receives: Device: Standard lead apron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During each procedure
Operator radiation exposure
Operator radiation exposure measured during endovascular aortic repair procedures using real-time personal dosimetry.
Measured: During each procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start3 Nov 2025
- Primary completion17 Jun 2027 (estimated)
- Study completion17 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Exposure to OperatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528144
- Sponsor's protocol ID
- KB-006/76/2025
- Acronym
- PROTECT-EVAR
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of the small sample size and the risk of participant identification.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Exposure and Operator Musculoskeletal Strain in Endovascular Aortic Repair: a Randomized Trial of Exoskeleton vs. Standard Aprons
- ClinicalTrials.gov ID
- NCT07528144
- Acronym / sponsor ID
- PROTECT-EVAR / KB-006/76/2025
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Samodzielny Publiczny Szpital Kliniczny nr 2 PUMUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 17 Jun 2027 (estimated)
- Study completion
- 17 Jun 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton-Supported Protection System | Experimental | Device: Exoskeleton-supported radiation protection systemEndovascular aortic repair procedures performed with an exoskeleton-supported radiation protection system with visor. |
| Standard Lead Apron | Active comparator | Device: Standard lead apronEndovascular aortic repair procedures performed with standard lead apron radiation protection. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exoskeleton-supported radiation protection systemAn exoskeleton-supported radiation protection system with visor used by the operator during endovascular aortic repair procedures. | Device | Exoskeleton-Supported Protection System |
| Standard lead apronA standard lead apron used by the operator during endovascular aortic repair procedures. | Device | Standard Lead Apron |
Primary outcome
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.
Operator radiation exposure
Time frame: During each procedure
Operator radiation exposure measured during endovascular aortic repair procedures using real-time personal dosimetry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of the small sample size and the risk of participant identification.
Related trials for Radiation Exposure to Operator
RecruitingObservational study
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
Operator Radiation Exposure
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Recruiting
Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access
Radiation Exposure
Active, not recruiting
Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)
Occupational Radiation Exposure in Interventional Cardiology
Recruiting
The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: The REDUCE Trial
Radiation Exposure, Radiation Exposure to Operator
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton-supported radiation protection system and Standard lead apron in people with Radiation Exposure to Operator and Endovascular Aortic Repair, run by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paweł Rynio, MD, PhD (914661156, p.rynio@usk2.szczecin.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors. (time frame: During each procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.