RADNCT06309407
Dosimeter Location in Pain Physicians
A study testing Hand Dosimeters and Standard Practice in people with RAD, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- RAD
- What is being tested?
- Hand Dosimeters and Standard Practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 21 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians actively performing fluoroscopy procedures at the Comprehensive Pain Center.
Who cannot join
- Those that do not want to participate in the quality improvement project.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Dosimeter Location and Measured Effective Radiation Dose in Pain Management Physicians
The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings.
The secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event.
- Conditions
- RAD
- Being tested
- Hand Dosimeters, Standard Practice
- Keywords
- Dosimeter, Radiation, Pain Medicine, Physician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand DosimetersDevice
Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants
Standard PracticeDevice
Participants only wore standard chest dosimeters
| Study group | Role | What they receive |
|---|---|---|
| Chest and Hand Dosimeters | Experimental | Subjects will wear both chest and hand dosimeters during all radiation procedures performed at the Comprehensive Pain Center during the study period. Receives: Device: Hand Dosimeters |
| Chest Dosimeter | Active comparator | Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Receives: Device: Standard Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Readings
Dose equivalent in mREM for each dosimeter that is worn by the subject.
Measured: 6 months
Secondary outcomes (1)
Total Number of Glove Breach Events
Number of intra-procedure glove breaches
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start23 Sep 2022
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RADStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to wear either chest dosimeters only or chest and hand dosimeters for the duration of the study in order to measure differences in radiation readings by each dosimeter location.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandy Christiansen, Oregon Health and Science University
- Investigators
- Sandy Christiansen, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309407
- Sponsor's protocol ID
- STUDY00024903
- Status last verified
- Jul 2024
- First submitted
- 22 Feb 2024
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimeter Location and Measured Effective Radiation Dose in Pain Management Physicians
- ClinicalTrials.gov ID
- NCT06309407
- Acronym / sponsor ID
- STUDY00024903
- Conditions
- RAD
- Keywords
- Dosimeter, Radiation, Pain Medicine, Physician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings.
The secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to wear either chest dosimeters only or chest and hand dosimeters for the duration of the study in order to measure differences in radiation readings by each dosimeter location.
| Arm | Type | Receives |
|---|---|---|
| Chest and Hand Dosimeters | Experimental | Device: Hand DosimetersSubjects will wear both chest and hand dosimeters during all radiation procedures performed at the Comprehensive Pain Center during the study period. |
| Chest Dosimeter | Active comparator | Device: Standard PracticeSubjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians actively performing fluoroscopy procedures at the Comprehensive Pain Center.
Key exclusion criteria (1 listed)
- Those that do not want to participate in the quality improvement project.
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 |
|---|---|---|
| Hand DosimetersParticipants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants | Device | Chest and Hand Dosimeters |
| Standard PracticeParticipants only wore standard chest dosimeters | Device | Chest Dosimeter |
Primary outcome
Radiation Readings
Time frame: 6 months
Dose equivalent in mREM for each dosimeter that is worn by the subject.
1 secondary outcome
Total Number of Glove Breach Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual data will not be shared with other researchers.
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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.
Sandy Christiansen, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Dosimeters and Standard Practice in people with RAD, run by Oregon Health and Science University at 1 site in United States.
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 Aug 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Readings (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 13 Aug 2024.