NCT01611454

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Occupational Exposure to Radiation

Interventions

Type	Name	Description
DEVICE	XPF thyroid collar	Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.
DEVICE	Standard 0.5mm lead equivalent thyroid collar	Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during the same type of comparator fluoroscopy guided interventions. Comparator arm uses same type of lead thyroid collar but the XPF under investigation.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-07-01
• Completion: 2011-08-01
• First posted: 2012-06-05
• Last updated: 2021-11-19
• Results posted: 2021-11-19

Locations

1 site across 1 country: United States