Radiation ExposureNCT00378053
A Prospective Study of Radiation Exposure to Surgeons
An observational study of Radiation Exposure, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Radiation Exposure
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Dec 2006
- 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
This study will only enroll the Surgeons of the Vanderbilt Hand and Upper Extremity Center. There will be no inclusion/exclusion criteria for the type of surgery that will be monitored, nor the patients that are having surgery. If a mini c-arm fluoroscopy is used the amount of radiation received by the Surgeon's hand for that surgery will be monitored by a gas-sterilized radiation ring dosimeter. The amount of scatter radiation the Surgeon will be exposed to will be recorded by a badge dosimeter located on the Surgeon's scrub collar, and one badge dosimeter that will be located under the required lead gown worn by the Surgeon.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center- Vanderbilt Orthopaedic Institute
Nashville, Tennessee, 37232-8828
About this study
The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine.
Read the detailed description
The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine. The amount of radiation that the Surgeons will be exposed to will be recorded by a ring dosimeter located on the Surgeons' hand, and two badge dosimeters (one above the scrub collar, and one underneath a lead gown at waist level).
- Conditions
- Radiation Exposure
- Keywords
- Radiation, Exposure, Hand, Orthopaedic, Surgeons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startSep 2006
- Study completionDec 2006
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.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 4 participants
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Donald H Lee, M.D., Principal investigator, VUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378053
- Sponsor's protocol ID
- 060829
- Status last verified
- Aug 2007
- First submitted
- 18 Sep 2006
- Last updated
- 16 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Radiation Exposure to Surgeons
- ClinicalTrials.gov ID
- NCT00378053
- Acronym / sponsor ID
- 060829
- Conditions
- Radiation Exposure
- Keywords
- Radiation, Exposure, Hand, Orthopaedic, Surgeons
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Dec 2006
- First posted
- 19 Sep 2006 (estimated)
- 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 purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine.
Detailed description
The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine. The amount of radiation that the Surgeons will be exposed to will be recorded by a ring dosimeter located on the Surgeons' hand, and two badge dosimeters (one above the scrub collar, and one underneath a lead gown at waist level).
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Aug 2007.
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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.
Donald H Lee, M.D. principal investigator
VUMC
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 Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2007. 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?
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.
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 16 Aug 2007.