N/A
N=106
New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)
Occupational Exposure to Radiation
Bottom Line
View on ClinicalTrials.gov: NCT01611454 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Percentage Change — 79.7; 71.9 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- XPF thyroid collar (Device); Standard 0.5mm lead equivalent thyroid collar (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baptist Health South Florida
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change |
79.7; 71.9 | — |
| SECONDARY Wearing Comfort of the Collar on a Scale From 0-100. |
85.0; 83.3 | — |
| SECONDARY Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars |
272.3; 98.2 | — |
| SECONDARY Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps |
224.1; 48.1 | — |
Summary
The PREFER II trial primary objective of the trial is to show how much radiation attenuation is provided by XPF thyroid collars in absolute and relative terms.
Eligibility Criteria
Inclusion Criteria
- Interventional Radiologists practicing in Baptist Cardiac & Vascular Institute
- consecutive endovascular procedure requiring C-arm fluoroscopy
Exclusion Criteria
- Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.
Data sourced from ClinicalTrials.gov (NCT01611454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.