Method for bAdge-dosi Monitoring of X-ray Exposure Values in Operating Theatre Surgery (MAVERIC)

July 13, 2026 updated by: University Hospital, Tours

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45000
        • University Hospital
      • Pessac, France, 33604
        • University Hospital
      • Toulouse, France, 31000
        • University Hospital
      • Tours, France, 37044
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

staff exposed to X-rays working in the operating room (TEST group)

Description

Inclusion Criteria:

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.
  • 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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Dosimeter alone
Dosimeter alone as usually used in hospital unit exposed to radiation
Experimental: Dosimeter combined with access badge
Dosimeter will be combined with the badge that providing access to hospital unit
Device: Badge-dosi
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Passive dosimeter wearing rate is assessed at M0, M3 and M6 by a declarative questionnaire (TEST group).
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
Difference in radiation measured in mSv between the BadgeDosi and the dosimeter alone (TEST group, M3 and M6).
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
Difference in radiation measured in mSv between the dosimeters of the TEST group and of the VIE control group (M3 and M6).
Month 3 and month 6
Collect user feedback on the ergonomics the BadgeDosi (TEST and VIE groups).
Time Frame: Month 3 and month 6
Questionnaire on feedback (ergonomics, usability, satisfaction) from the TEST group and the VIE control group (M3 and M6).
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
Difference in radiation measured in mSv between healthcare center and staff's homes (HOME control group, M3 and M6).
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.
Questionnaire on feedback from the TEST group M3 and M6
Month 3 and month 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DR240215 - MAVERIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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