New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II) — PREFER-II  

Occupational Exposure to Radiation Clinical Trial

Official title: Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Occupational Exposure to Radiation

• NCT number: NCT01611454
• Study type: Interventional
• Source: Baptist Health South Florida
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Completion date: August 2011