X-RayMAVERICNCT06659939
Method for bAdge-dosi Monitoring of X-ray Exposure Values in Operating Theatre Surgery
A study testing Badge-dosi in people with X-Ray, run by University Hospital, Tours at 4 sites in France.
Trial summary
Surgical procedures involving X-rays in the operating room have increased in recent years, thereby increasing the exposure of operating room staff to ionizing radiation. An individual dosimeter makes it possible to record the radiation exposure to which these personnel are exposed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- X-Ray
- What is being tested?
- Badge-dosi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Oct 2024to Sep 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- TEST group :
- People working in the operating room at least 80% of the time (excluding people working less than 80% of the time).
- Have been monitored by a delayed-reading dosimeter for at least 1 year.
- Carry an access card (i.e. be the holder).
- LIFE group :
- Person working in the same centre as the people in the TEST group.
Show all 10Show fewer
- Person not exposed to radiation at their workstation
- Holder of an access card
- HOME group :
- Person working in the same centre as people in the TEST Group and live near the center
Who cannot join
- For all Groups :
- Person objecting to data processing
- Interns/externs/non-permanent staff likely to change jobs during the study period
- Person who had a nuclear medicine examination within 15 days before the start of the study
- Anyone who had internal vectorised therapy with iodine-131 or Lu-177 within 30 days before the start of the study.
Trial locations and contacts
4 sites in 1 country.
France4 sites
University hospital
Orléans, 45000
University hospital
Pessac, 33604
University hospital
Toulouse, 31000
University hospital
Tours, 37044
About this study
Official title: Method for bAdge-dosi Monitoring of X-ray Exposure Values in Operating Theatre Surgery: a Multicentre Randomised Trial
Surgical procedures involving X-rays in the operating room have increased in recent years, thereby increasing the exposure of operating room staff to ionizing radiation. An individual dosimeter makes it possible to record the radiation exposure to which these personnel are exposed. However, it has been noticed that these dosimeters are not thoroughly worn, consequently the radiation doses recorded are not reliable.
In order to increase the proportion of dosimeters systematically worn in the operating room, we study the impact of the association of the passive dosimeter with the hospital access badge (forming the Badge-Dosi). A first pilot study was carried out at Tours University Hospital showing the effectiveness of this concept. With the present study, we carry out a multicenter study. Our hypothesis is that the Badge-Dosi allows a significant increase of dosimeter use in the operating room, which improves the reliability of the monitoring of personnel.
- Conditions
- X-Ray
- Being tested
- Badge-dosi
- Keywords
- radioprotection, dosimeter, surgical staff, operating room, radiation monitoring, Badge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Badge-dosiDevice
The intervention assessed consists in linking the radiation dosimeter to the access badge (which practitioners wear at all times) in order to improve compliance with radiation dosimeter wear among practitioners exposed to X-rays.
| Study group | Role | What they receive |
|---|---|---|
| Dosimeter alone | No intervention | Dosimeter alone as usually used in hospital unit exposed to radiation |
| Dosimeter combined with access badge | Experimental | Dosimeter will be combined with the badge that providing access to hospital unit Receives: Device: Badge-dosi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the wearing of dosimeters by staff exposed to X-rays and working in the operating room thanks to the BadgeDosi solution in order to make the exposure measurements taken more reliable and interpretable compared to the passive dosimeter alone. (TES
Passive dosimeter wearing status (alone versus BadgeDosi) assessed once by an independent observer over the M6 period (during the sixth month of the study, TEST group).
Measured: 6 months
Secondary outcomes (6)
Evaluate the wearing rate the passive dosimeter assessed by questionnaire at M0, M3 and M6 (TEST group)
Passive dosimeter wearing rate is assessed at M0, M3 and M6 by a declarative questionnaire (TEST group).
Measured: Month 0, month 3 and month 6
Study the evolution of radiation read on the BadgeDosi versus passive dosimeter alone among agents working in the operating room (TEST group).
Difference in radiation measured in mSv between the BadgeDosi and the dosimeter alone (TEST group, M3 and M6).
Measured: Month 3 and month 6
Study the variations of doses of a control group wearing the BadgeDosi but not exposed to ionizing radiation as part of their activity in the hospital (VIE group).
Difference in radiation measured in mSv between the dosimeters of the TEST group and of the VIE control group (M3 and M6).
Measured: Month 3 and month 6
Collect user feedback on the ergonomics the BadgeDosi (TEST and VIE groups).
Questionnaire on feedback (ergonomics, usability, satisfaction) from the TEST group and the VIE control group (M3 and M6).
Measured: Month 3 and month 6
Monitor natural radioactivity between the healthcare center and the staff's homes. Special care is taken so the distribution of the places of residence of the staff around the hospital is represented (HOME group).
Difference in radiation measured in mSv between healthcare center and staff's homes (HOME control group, M3 and M6).
Measured: Month 3 and month 6
Collect user feedback on the use of the UV box placed in the changing rooms for disinfection of personal objects (including but not limited to the BadgeDosi) entering the OR department (TEST groups).
Questionnaire on feedback from the TEST group M3 and M6
Measured: Month 3 and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Oct 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-RayStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659939
- Sponsor's protocol ID
- DR240215 - MAVERIC
- Acronym
- MAVERIC
- Status last verified
- Jul 2026
- First submitted
- 24 Oct 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method for bAdge-dosi Monitoring of X-ray Exposure Values in Operating Theatre Surgery: a Multicentre Randomised Trial
- ClinicalTrials.gov ID
- NCT06659939
- Acronym / sponsor ID
- MAVERIC / DR240215 - MAVERIC
- Conditions
- X-Ray
- Keywords
- radioprotection, dosimeter, surgical staff, operating room, radiation monitoring, Badge
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Oct 2024 (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.
Surgical procedures involving X-rays in the operating room have increased in recent years, thereby increasing the exposure of operating room staff to ionizing radiation. An individual dosimeter makes it possible to record the radiation exposure to which these personnel are exposed. However, it has been noticed that these dosimeters are not thoroughly worn, consequently the radiation doses recorded are not reliable.
In order to increase the proportion of dosimeters systematically worn in the operating room, we study the impact of the association of the passive dosimeter with the hospital access badge (forming the Badge-Dosi). A first pilot study was carried out at Tours University Hospital showing the effectiveness of this concept. With the present study, we carry out a multicenter study. Our hypothesis is that the Badge-Dosi allows a significant increase of dosimeter use in the operating room, which improves the reliability of the monitoring of personnel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosimeter alone | No intervention | –Dosimeter alone as usually used in hospital unit exposed to radiation |
| Dosimeter combined with access badge | Experimental | Device: Badge-dosiDosimeter will be combined with the badge that providing access to hospital unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- People working in the operating room at least 80% of the time (excluding people working less than 80% of the time).
- Have been monitored by a delayed-reading dosimeter for at least 1 year.
- Carry an access card (i.e. be the holder).
- Person working in the same centre as the people in the TEST group.
- Person not exposed to radiation at their workstation
Key exclusion criteria (5 listed)
- Person objecting to data processing
- Interns/externs/non-permanent staff likely to change jobs during the study period
- Person who had a nuclear medicine examination within 15 days before the start of the study
- Anyone who had internal vectorised therapy with iodine-131 or Lu-177 within 30 days before the start of the study.
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 |
|---|---|---|
| Badge-dosiThe intervention assessed consists in linking the radiation dosimeter to the access badge (which practitioners wear at all times) in order to improve compliance with radiation dosimeter wear among practitioners exposed to X-rays. | Device | Dosimeter combined with access badge |
Primary outcome
Improve the wearing of dosimeters by staff exposed to X-rays and working in the operating room thanks to the BadgeDosi solution in order to make the exposure measurements taken more reliable and interpretable compared to the passive dosimeter alone. (TES
Time frame: 6 months
Passive dosimeter wearing status (alone versus BadgeDosi) assessed once by an independent observer over the M6 period (during the sixth month of the study, TEST group).
6 secondary outcomes
Evaluate the wearing rate the passive dosimeter assessed by questionnaire at M0, M3 and M6 (TEST group)
Time frame: Month 0, month 3 and month 6
Study the evolution of radiation read on the BadgeDosi versus passive dosimeter alone among agents working in the operating room (TEST group).
Time frame: Month 3 and month 6
Study the variations of doses of a control group wearing the BadgeDosi but not exposed to ionizing radiation as part of their activity in the hospital (VIE group).
Time frame: Month 3 and month 6
Collect user feedback on the ergonomics the BadgeDosi (TEST and VIE groups).
Time frame: Month 3 and month 6
Monitor natural radioactivity between the healthcare center and the staff's homes. Special care is taken so the distribution of the places of residence of the staff around the hospital is represented (HOME group).
Time frame: Month 3 and month 6
Collect user feedback on the use of the UV box placed in the changing rooms for disinfection of personal objects (including but not limited to the BadgeDosi) entering the OR department (TEST groups).
Time frame: Month 3 and month 6.
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 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Badge-dosi in people with X-Ray, run by University Hospital, Tours at 4 sites 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 10 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
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?
Improve the wearing of dosimeters by staff exposed to X-rays and working in the operating room thanks to the BadgeDosi solution in order to make the exposure measurements taken more reliable and interpretable compared to the passive dosimeter alone. (TES (time frame: 6 months). 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 14 Jul 2026.