New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER) (PREFER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01450969|
Recruitment Status : Completed
First Posted : October 13, 2011
Last Update Posted : September 25, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2011|
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.
- Radiation attenuation in percentage (%) and in absolute terms (μSv/min) [ Time Frame: The attenuation is assessed directly after each procedure (day 1) ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|