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NCT01910272 · ClinicalTrials.gov registry record
Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures
A clinical trial, sponsored by University of California, San Diego.
- Completed
- Registry status
- 11
- Enrollment target
NCT01910272 is a clinical trial that has completed, run by University of California, San Diego. The registered enrollment target is 11 participants.
The verdict
NCT01910272 has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- 11 participants
- Enrollment target
Study Summary
Invasive cardiac procedures involve procedural guidance with x-rays in the form of fluoroscopy. X-ray exposure poses a potential risk of acute and long-term complications to staff involved in these procedures. Lead shields are placed between the operators (on their left side) and the x-ray source to limit exposure. However as the operator requires direct access to the patient and x-ray scatter occurs, full protection is not possible. Lead gowns, thyroid collars, and leaded glasses are typically worn to protect the body, thyroid, and eyes respectively, but their thickness is limited by their relatively heavy weight. Nevertheless this leaves the brain exposed. Further, interest in the risk of brain cancer in invasive cardiologists has re-emerged after a recent report of left-sided brain cancer in primary operators of interventional cardiology procedures. Lead caps have been tested in the past but the relatively heavyweight of lead has limited wide-spread implementation. The cap typically worn during invasive procedures is lightweight, has no significant x-ray absorption properties, and is worn to help maintain a sterile environment. A novel, lead-free cap, composed mainly of barium sulfate and bismuth oxide, has been developed that has been shown to absorb x-rays while being significantly lighter than lead. The investigators propose using multiple x-ray detectors to test exposure differences between the primary and secondary operators, the left side and right side of the head, and absorption via a lead-free cap.
Interventions
- DEVICE All subjects are wearing the non-lead attenuation cap (BLOXR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01910272
The ClinicalTrials.gov registry entry for NCT01910272 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which All subjects are wearing the non-lead attenuation cap (BLOXR) is the first listed.
NCT01910272 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01910272 about?
NCT01910272 is a clinical study titled "Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures". Invasive cardiac procedures involve procedural guidance with x-rays in the form of fluoroscopy. X-ray exposure poses a potential risk of acute and long-term complications to staff involved in these procedures. Lead shields are placed between the operators (on their left side) and the x-ray source to...
What is the current status of trial NCT01910272?
This trial is currently completed. The enrollment target is 11 participants. The study started on 2013-01.
What interventions are being tested in trial NCT01910272?
The interventions under investigation include: All subjects are wearing the non-lead attenuation cap (BLOXR) (DEVICE).
Who is sponsoring clinical trial NCT01910272?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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