Radiation ExposureNCT04078165
Suspended Personal Protection System Versus Conventional Protection (Aka Zero-Gravity vs Shield and Apron)
A study testing Zero-Gravity and Conventional radiation protection in people with Radiation Exposure, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
This trial investigates operator radiation doses when performing standardized procedures using two different means of radiation protection, namely conventional lead shield and apron versus suspended protection system (Zero-Gravity, ZG). The performed procedure is standard endovascular aortic repair (EVAR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Zero-Gravity and Conventional radiation protection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFinland
- Study dates
- 2 Sep 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients eligible for standard EVAR at Helsinki University Hospital
Who cannot join
- any additional interventions such as embolization, recanalization, screw fixation
Trial locations and contacts
1 site in 1 country.
About this study
This trial investigates operator radiation doses when performing standardized procedures using two different means of radiation protection, namely conventional lead shield and apron versus suspended protection system (Zero-Gravity, ZG). The performed procedure is standard endovascular aortic repair (EVAR). The hypothesis is that ZG offers superior protection for the operator.
Read the detailed description
Endovascular aneurysm repair (EVAR) is less invasive than open surgery, yet the procedure causes sustained radiation exposure to the operator and has a potential risk of radiation-induced skin damage and later malignancy. The deterministic (threshold limited) adverse effects of radiation have been known since the invention of the X-ray in 1895, but the stochastic (non-threshold limited) adverse effects are not so apparent and thus need constant refinement. Diligent usage of radiation protection and abidance to ALARA (As Low As Reasonably Achievable) principles minimizes cumulative radiation exposure.
The lens of the human eye is very sensitive to radiation and cataract formation has been reported among medical interventional practitioners. Previous research into differences between conventional protection (apron and shields) and suspended personal protection (Zero Gravity, ZG) claims superior protection, especially to the lens, while using a suspended personal protection system. Ancillary lead glasses may be needed to fully protect the eyes. In other studies randomization of methods was deemed irrelevant due to expected dramatic differences between conventional and suspended protection systems. In addition standardization of procedures was lacking, because of cohort matching difficulties. The methods of measuring scattered radiation varies among previous studies and we have found the evaluation methods flawed.
The aim of this research is to evaluate the total radiation exposure to the interventionalist and assistant during infrarenal abdominal aortic aneurysm stent-grafting, while using either conventional protection (lead apron and shield) or a suspended personal protection system (Zero-Gravity, ZG). The ZG system consists of a lead shield that is suspended from the ceiling or a separate hanger that permits freedom of motion of the operator, and with no weight supported by the operator.
The total radiation doses have seen considerate reduction already in Helsinki, Finland and lower doses may influence the efficacy of the ZG system. Improper usage of the ZG protection gear as a whole can lead to inefficient protection.
The operator's subjective ergonomic feel and experience will be evaluated with a postoperative questionnaire.
The patients will be randomized into two groups: one where the operator will be using conventional protection (shield and apron) and one where the operator will be using the ZG system. The data will be collected during a four month period, which includes approximately 50 standardized EVAR operations.
Dosimeters will be used to collect the data during the procedures and are placed in various anatomical regions (eye, chest, leg, stomach, control outside protection). The exposure dosage to the eye is measured with EYE-D (Eye lens TLD dosimeter) and other measurements are done using DIS-1 dosimeters. Other data collected includes total fluoroscopy duration, total dose area product (DAP), entrance skin air KERMA (ESAK), and body mass index.
The anonymity and rights of participants will be protected. The health of patients is of uttermost importance and there is no difference in care received.
The planning and design has started since May 2019. Data collection will commence after dosimeter testing in September 2019 and last until December 2019. After data analysis the results will be disseminated in Spring 2020. Literature review will take place parallel to the research.
- Conditions
- Radiation Exposure
- Being tested
- Zero-Gravity, Conventional radiation protection
- Keywords
- radiation protection, EVAR, endovascular surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero-GravityDevice
Free-floating, suspended personal radiation protection
Conventional radiation protectionDevice
Standard lead shields and aprons
| Study group | Role | What they receive |
|---|---|---|
| Zero-Gravity | Experimental | In this group, the operator uses the Zero-Gravity protection system Receives: Device: Zero-Gravity |
| Conventional | Active comparator | In this group, the operator uses conventional radiation protection Receives: Device: Conventional radiation protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure
Radiation dosages in multiple dosimeters on operator
Measured: During operations
Secondary outcomes (3)
Fluoroscopy duration
Duration of fluoroscopy in seconds
Measured: During operation
Fluoroscopy dose area product (DAP)
Patient radiation exposure
Measured: During operation
Entrance skin air KERMA
Patient radiation exposure
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start2 Sep 2019
- Primary completion31 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation ExposureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarit Venermo, Helsinki University Central Hospital
- Investigators
- Maarit Venermo, MD, PhD, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078165
- Sponsor's protocol ID
- 2019/09/01
- Status last verified
- May 2021
- First submitted
- 30 Aug 2019
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serna Santos J, Kaasalainen T, Laukontaus S, Bjorkman P, Heinola I, Laine M, Vikatmaa P, Pekkarinen A, Venermo M, Aho P. The Effect of a Suspended Radiation Protection System on Occupational Radiation Doses During Infrarenal EVAR Procedures: A Randomised Controlled Study. Eur J Vasc Endovasc Surg. 2024 Mar;67(3):435-443. doi: 10.1016/j.ejvs.2023.08.039. Epub 2023 Aug 22.
PubMed 37611731
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suspended Personal Protection System Versus Conventional Protection (Aka Zero-Gravity vs Shield and Apron)
- ClinicalTrials.gov ID
- NCT04078165
- Acronym / sponsor ID
- 2019/09/01
- Conditions
- Radiation Exposure
- Keywords
- radiation protection, EVAR, endovascular surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 4 Sep 2019 (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.
This trial investigates operator radiation doses when performing standardized procedures using two different means of radiation protection, namely conventional lead shield and apron versus suspended protection system (Zero-Gravity, ZG). The performed procedure is standard endovascular aortic repair (EVAR). The hypothesis is that ZG offers superior protection for the operator.
Detailed description
Endovascular aneurysm repair (EVAR) is less invasive than open surgery, yet the procedure causes sustained radiation exposure to the operator and has a potential risk of radiation-induced skin damage and later malignancy. The deterministic (threshold limited) adverse effects of radiation have been known since the invention of the X-ray in 1895, but the stochastic (non-threshold limited) adverse effects are not so apparent and thus need constant refinement. Diligent usage of radiation protection and abidance to ALARA (As Low As Reasonably Achievable) principles minimizes cumulative radiation exposure.
The lens of the human eye is very sensitive to radiation and cataract formation has been reported among medical interventional practitioners. Previous research into differences between conventional protection (apron and shields) and suspended personal protection (Zero Gravity, ZG) claims superior protection, especially to the lens, while using a suspended personal protection system. Ancillary lead glasses may be needed to fully protect the eyes. In other studies randomization of methods was deemed irrelevant due to expected dramatic differences between conventional and suspended protection systems. In addition standardization of procedures was lacking, because of cohort matching difficulties. The methods of measuring scattered radiation varies among previous studies and we have found the evaluation methods flawed.
The aim of this research is to evaluate the total radiation exposure to the interventionalist and assistant during infrarenal abdominal aortic aneurysm stent-grafting, while using either conventional protection (lead apron and shield) or a suspended personal protection system (Zero-Gravity, ZG). The ZG system consists of a lead shield that is suspended from the ceiling or a separate hanger that permits freedom of motion of the operator, and with no weight supported by the operator.
The total radiation doses have seen considerate reduction already in Helsinki, Finland and lower doses may influence the efficacy of the ZG system. Improper usage of the ZG protection gear as a whole can lead to inefficient protection.
The operator's subjective ergonomic feel and experience will be evaluated with a postoperative questionnaire.
The patients will be randomized into two groups: one where the operator will be using conventional protection (shield and apron) and one where the operator will be using the ZG system. The data will be collected during a four month period, which includes approximately 50 standardized EVAR operations.
Dosimeters will be used to collect the data during the procedures and are placed in various anatomical regions (eye, chest, leg, stomach, control outside protection). The exposure dosage to the eye is measured with EYE-D (Eye lens TLD dosimeter) and other measurements are done using DIS-1 dosimeters. Other data collected includes total fluoroscopy duration, total dose area product (DAP), entrance skin air KERMA (ESAK), and body mass index.
The anonymity and rights of participants will be protected. The health of patients is of uttermost importance and there is no difference in care received.
The planning and design has started since May 2019. Data collection will commence after dosimeter testing in September 2019 and last until December 2019. After data analysis the results will be disseminated in Spring 2020. Literature review will take place parallel to the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero-Gravity | Experimental | Device: Zero-GravityIn this group, the operator uses the Zero-Gravity protection system |
| Conventional | Active comparator | Device: Conventional radiation protectionIn this group, the operator uses conventional radiation protection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients eligible for standard EVAR at Helsinki University Hospital
Key exclusion criteria (1 listed)
- any additional interventions such as embolization, recanalization, screw fixation
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 |
|---|---|---|
| Zero-GravityFree-floating, suspended personal radiation protection | Device | Zero-Gravity |
| Conventional radiation protectionStandard lead shields and aprons | Device | Conventional |
Primary outcome
Radiation exposure
Time frame: During operations
Radiation dosages in multiple dosimeters on operator
3 secondary outcomes
Fluoroscopy duration
Time frame: During operation
Fluoroscopy dose area product (DAP)
Time frame: During operation
Entrance skin air KERMA
Time frame: During operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Derived from this study: PubMed 37611731Serna Santos J, Kaasalainen T, Laukontaus S, Bjorkman P, Heinola I, Laine M, Vikatmaa P, Pekkarinen A, Venermo M, Aho P. The Effect of a Suspended Radiation Protection System on Occupational Radiation Doses During Infrarenal EVAR Procedures: A Randomised Controlled Study. Eur J Vasc Endovasc Surg. 2024 Mar;67(3):435-443. doi: 10.1016/j.ejvs.2023.08.039. Epub 2023 Aug 22.
- Individual participant dataSharing planned: No
Related trials for Radiation Exposure
Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
RecruitingObservational study
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
Operator Radiation Exposure
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
RecruitingPhase 3
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin
Recruiting
Nano-Silver Versus Bioactive Glass for Primary Teeth Exposed to Therapeutic Radiation
Radiation Caries
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. This study is not recruiting at the moment.
Maarit Venermo, MD, PhD study director
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zero-Gravity and Conventional radiation protection in people with Radiation Exposure, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 May 2021. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure (time frame: During operations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078165, which also lists 1 linked publication.
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 May 2021.