New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II) (PREFER-II)
|Occupational Exposure to Radiation||Device: XPF thyroid collar Device: Standard 0.5mm lead equivalent thyroid collar|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)|
- Radiation attenuation in percentage (%) [ Time Frame: 1 day ]The null hypothesis is that the XPF thyroid collar is equal to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission in relative (%) terms. The alternative hypothesis is that the XPF thyroid collar is superior or inferior to the standard thyroid collar. Based on our results obtained during the 60 procedures (PREFER trial), 150 procedures are required to demonstrate a significant difference with an alpha level of 5% and a power of 80%.
- Wearing comfort of the collar on a scale from 0-100. [ Time Frame: 1 day ]Operators are asked directly after each procedure to rate the wearing comfort
- Radiation attenuation in absolute terms (uSv) [ Time Frame: 1 day ]
|Study Start Date:||May 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: XPF thyroid collar
Administration of the XPF Thyroid Collar.
Device: XPF thyroid collar
Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.
Active Comparator: Equivalent collar
Administration of the Standard 0.5mm lead-equivalent thyroid collar.
Device: Standard 0.5mm lead equivalent thyroid collar
Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions.
The PREFER II trial has three main objectives. The primary objective of the trial is to show how much radiation attenuation is provided by XPF thyroid collars 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 150 consecutive interventional procedures requiring C-arm fluoroscopy performed at BCVI. 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 2 radiation detectors (TLDs, one inside and one outside the thyroid 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: NCT01611454
|United States, Florida|
|Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute|
|Miami, Florida, United States, 33176|
|Principal Investigator:||Barry T Katzen, MD||Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute|
|Principal Investigator:||Heiko Uthoff, MD||Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute|