Radiation ExposureDOSE RPW-CRINCT05561439
Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France
An observational study of Radiation Exposure, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The objective of this study is to review the results of annual radiation doses received by interventional cardiologists and radiologists in France. The results of this study will allow the improvement of classification of interventional cardiology and radiology activities and procedures to help define radiation dose… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Dosimetric monitoring
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2022to 31 Dec 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants in the study will be interventional cardiologists and interventional radiologists exposed to radiation during their interventional procedures performed as part of their activity.
Who may be able to join
- Physician performing interventional cardiology or radiology procedures with a fixed C-arm system
- Physician systematically wearing at least one of the following personal dosimeters: whole body, extremities, lens.
Who cannot join
- Physician who did not perform an interventional procedure during the observation period (2019-2021)
- For the primary endpoint by year, physician with more than 3 months of missing data (more than one 3-month period or more than 3 1-month periods)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists
The objective of this study is to review the results of annual radiation doses received by interventional cardiologists and radiologists in France. The results of this study will allow the improvement of classification of interventional cardiology and radiology activities and procedures to help define radiation dose constraints for occupational exposure, according to the number and types of procedures performed.
The study is based on the hypothesis that some specialties in interventional cardiology (cardiology or rythmology procedures) and in interventional radiology (vascular, neuroradiology, osteoarticular) and some types of procedures present greater exposure risks for interventional cardiologists and radiologists. It is expected that the annual radiation dose limits for workers can be exceeded if good practices for both patient and worker radiation protection are not applied. Also, dosimetry equipment used to detect radiation dose although provided to the workers are not systematically worn by the physician during the procedure . The study is likely to show that for an equivalent speciality and number of procedures per type of act, the correct use of collective and personal radiation protection equipment (préciser) will lower occupational radiation exposure of physician . Similarly, for an equivalent activity and number of procedures per type of act , a trained physician would have a lower occupational exposure than an untrained physician. The physician's radiation exposure should therefore increase with a greater number of procedures per type of procedure performed and as the radiation dose delivered to the patient increase. Finally, there would be a different correlation between patient's radiation dose and physician's exposure depending on specialty, procedures, modality, experience and availability and use of collective and personal radiation protection equipment.
- Conditions
- Radiation Exposure
- Being tested
- Dosimetric monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosimetric monitoringOther
Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021
| Study group | Role | What they receive |
|---|---|---|
| Cardiology: Coronary/Valvular | Not described Receives: Other: Dosimetric monitoring | |
| Cardiology: Rhythmology | Not described Receives: Other: Dosimetric monitoring | |
| Cardiology: Mixed | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Simple Vascular | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Complex Vascular | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Mixed Vascular | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Simple Osteoarticular | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Complex Osteoarticular | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Mixed Osteoarticular | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Simple Neuroradiology | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Complex Neuroradiology | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Mixed Neuroradiology | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Mixed | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Simple Oncology | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Complex Oncology | Not described Receives: Other: Dosimetric monitoring | |
| Radiology: Mixed Oncology | Not described Receives: Other: Dosimetric monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2019
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2020
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2021
Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2019
Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2020
Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2021
Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2019
Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2020
Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
mSv
Measured: 2021
Secondary outcomes (58)
Availability and frequency of use for each passive dosimeter
Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
Availability and frequency of use for each passive dosimeter
Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Availability and frequency of use for each passive dosimeter
Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019,
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019, 2020 and 2021
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Gloves use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2019
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2020
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed
Measured: 2021
Patient radiation protection training status according to specialty, activity and type of procedures performed
Up-to-date/needs renewing/never completed
Measured: 2019,
Patient radiation protection training status according to specialty, activity and type of procedures performed
Up-to-date/needs renewing/never completed
Measured: 2020
Patient radiation protection training status according to specialty, activity and type of procedures performed
Up-to-date/needs renewing/never completed
Measured: 2021
Worker radiation protection training status according to specialty, activity and type of procedures performed
Up-to-date/needs renewing/never completed
Measured: 2019
Worker radiation protection training status according to specialty, activity and type of procedures performed
Up-to-date/needs renewing/never completed
Measured: 2020
Worker radiation protection training status according to specialty, activity and type of procedures performed
Up-to-date/needs renewing/never completed
Measured: 2021
Physician exposure according to total number of procedures
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2019
Physician exposure according to total number of procedures
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2020
Physician exposure according to total number of procedures
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2021
Physician exposure according to number of procedures by type of specialty
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2019
Physician exposure according to number of procedures by type of specialty
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2020
Physician exposure according to number of procedures by type of specialty
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2021
Physician exposure according to number of procedures by modality
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2219
Physician exposure according to number of procedures by modality
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2020
Physician exposure according to number of procedures by modality
mSv: Information taken from Dosimetry Archiving and Communication System
Measured: 2021
Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
Gy.cm²
Measured: 2019
Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
Gy.cm²
Measured: 2020
Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
Gy.cm²
Measured: 2021
Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
mGy
Measured: 2019
Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
mGy
Measured: 2020
Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
mGy
Measured: 2021
Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
mGy.cm
Measured: 2019
Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
mGy.cm
Measured: 2020
Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed
mGy.cm
Measured: 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start2 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril Duverger, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561439
- Sponsor's protocol ID
- NIMAO/2021-01 /CD-01
- Acronym
- DOSE RPW-CRI
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists
- ClinicalTrials.gov ID
- NCT05561439
- Acronym / sponsor ID
- DOSE RPW-CRI / NIMAO/2021-01 /CD-01
- Conditions
- Radiation Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Sep 2022 (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 objective of this study is to review the results of annual radiation doses received by interventional cardiologists and radiologists in France. The results of this study will allow the improvement of classification of interventional cardiology and radiology activities and procedures to help define radiation dose constraints for occupational exposure, according to the number and types of procedures performed.
The study is based on the hypothesis that some specialties in interventional cardiology (cardiology or rythmology procedures) and in interventional radiology (vascular, neuroradiology, osteoarticular) and some types of procedures present greater exposure risks for interventional cardiologists and radiologists. It is expected that the annual radiation dose limits for workers can be exceeded if good practices for both patient and worker radiation protection are not applied. Also, dosimetry equipment used to detect radiation dose although provided to the workers are not systematically worn by the physician during the procedure . The study is likely to show that for an equivalent speciality and number of procedures per type of act, the correct use of collective and personal radiation protection equipment (préciser) will lower occupational radiation exposure of physician . Similarly, for an equivalent activity and number of procedures per type of act , a trained physician would have a lower occupational exposure than an untrained physician. The physician's radiation exposure should therefore increase with a greater number of procedures per type of procedure performed and as the radiation dose delivered to the patient increase. Finally, there would be a different correlation between patient's radiation dose and physician's exposure depending on specialty, procedures, modality, experience and availability and use of collective and personal radiation protection equipment.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Cardiology: Coronary/Valvular | – | Other: Dosimetric monitoring |
| Cardiology: Rhythmology | – | Other: Dosimetric monitoring |
| Cardiology: Mixed | – | Other: Dosimetric monitoring |
| Radiology: Simple Vascular | – | Other: Dosimetric monitoring |
| Radiology: Complex Vascular | – | Other: Dosimetric monitoring |
| Radiology: Mixed Vascular | – | Other: Dosimetric monitoring |
| Radiology: Simple Osteoarticular | – | Other: Dosimetric monitoring |
| Radiology: Complex Osteoarticular | – | Other: Dosimetric monitoring |
| Radiology: Mixed Osteoarticular | – | Other: Dosimetric monitoring |
| Radiology: Simple Neuroradiology | – | Other: Dosimetric monitoring |
| Radiology: Complex Neuroradiology | – | Other: Dosimetric monitoring |
| Radiology: Mixed Neuroradiology | – | Other: Dosimetric monitoring |
| Radiology: Mixed | – | Other: Dosimetric monitoring |
| Radiology: Simple Oncology | – | Other: Dosimetric monitoring |
| Radiology: Complex Oncology | – | Other: Dosimetric monitoring |
| Radiology: Mixed Oncology | – | Other: Dosimetric monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in the study will be interventional cardiologists and interventional radiologists exposed to radiation during their interventional procedures performed as part of their activity.
Key inclusion criteria (2 listed)
- Physician performing interventional cardiology or radiology procedures with a fixed C-arm system
- Physician systematically wearing at least one of the following personal dosimeters: whole body, extremities, lens.
Key exclusion criteria (2 listed)
- Physician who did not perform an interventional procedure during the observation period (2019-2021)
- For the primary endpoint by year, physician with more than 3 months of missing data (more than one 3-month period or more than 3 1-month periods)
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 |
|---|---|---|
| Dosimetric monitoringDosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021 | Other | Cardiology: Coronary/Valvular, Cardiology: Mixed, Cardiology: Rhythmology, Radiology: Complex Neuroradiology, Radiology: Complex Oncology, Radiology: Complex Osteoarticular, Radiology: Complex Vascular, Radiology: Mixed, Radiology: Mixed Neuroradiology, Radiology: Mixed Oncology, Radiology: Mixed Osteoarticular, Radiology: Mixed Vascular, Radiology: Simple Neuroradiology, Radiology: Simple Oncology, Radiology: Simple Osteoarticular, Radiology: Simple Vascular |
Primary outcome
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2019
mSv
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2020
mSv
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2021
mSv
Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2019
mSv
Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2020
mSv
Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2021
mSv
Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2019
mSv
Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2020
mSv
Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed
Time frame: 2021
mSv
58 secondary outcomes
Availability and frequency of use for each passive dosimeter
Time frame: 2019
Availability and frequency of use for each passive dosimeter
Time frame: 2020
Availability and frequency of use for each passive dosimeter
Time frame: 2021
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019,
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019, 2020 and 2021
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
Gloves use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2019
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2020
Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed
Time frame: 2021
Patient radiation protection training status according to specialty, activity and type of procedures performed
Time frame: 2019,
Patient radiation protection training status according to specialty, activity and type of procedures performed
Time frame: 2020
Patient radiation protection training status according to specialty, activity and type of procedures performed
Time frame: 2021
Worker radiation protection training status according to specialty, activity and type of procedures performed
Time frame: 2019
Worker radiation protection training status according to specialty, activity and type of procedures performed
Time frame: 2020
Worker radiation protection training status according to specialty, activity and type of procedures performed
Time frame: 2021
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 10 Mar 2025.
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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.
Cyril Duverger principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Exposure, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 2 inclusion and 2 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 10 Mar 2025. 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 France. 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?
Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed (time frame: 2019). The study lists 9 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 10 Mar 2025.