New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)
The PREFER Trial primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)|
- Radiation attenuation in percentage (%) and in absolute terms (μSv/min) [ Time Frame: The attenuation is assessed directly after each procedure (day 1) ] [ Designated as safety issue: No ]The null hypothesis is that the XPF thyroid collar is inferior to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission. The alternative hypothesis is that the XPF thyroid collar is non-inferior to the standard thyroid collar. If there is truly no difference between standard and XPF thyroid collars, then 60 patients are required to be 95% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -0.7% transmission rate and -0.013 μSv/min.
- Wearing comfort of the XPF cap and collar on a scale from 0-100. [ Time Frame: (day 1) Operators are asked directly after each procedure to rate the wearing comfort ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
All operators are Interventional Radiologists and co-investigators. Prior to start of the study, all operators are asked to provide written informed consent to participate in the study.
The PREFER Trial has three main objectives. The primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms. The secondary objective of the study is to measure and compare the amount of radiation that interventional radiologists are exposed to per case in an interventional suite setting using FDA approved XPF thyroid collars or standard 0.5 mm Pb equivalent thyroid collars. The third objective is to assess the operator comfort wearing the XPF protection devices. In order to achieve these objectives, measurements will be performed in 60 consecutive endovascular procedures requiring C-arm fluoroscopy performed at BCVI. Participants will be asked to wear an XPF cap (weighing approximately 100 grams) in every study procedure. Furthermore, a prospective randomization will be performed, assigning participants to wear their own standard 0.5 mm Pb equivalent thyroid collar or to wear the FDA approved XPF thyroid collar. Radiation exposure will be monitored with 4 radiation detectors (TLDs, 2 attached to the cap, 2 attached to the collar) which the participant is required to wear. After each procedure the participant will be asked to rate the comfort of wearing the devices on a scale from 1 to 100.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450969
|United States, Florida|
|Baptist Hospital of Miami, Miami Cardiac and Vascular Institute|
|Miami, Florida, United States, 33176|
|Principal Investigator:||Barry T. Katzen, MD||Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute|
|Principal Investigator:||Heiko Uthoff, MD||Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute|