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

Baptist Health South Florida

Status: Completed

Conditions: Occupational Exposure to Radiation

Treatments: Device: Standard 0.5mm lead equivalent thyroid collar; Device: XPF thyroid collar

Study type: Interventional

Funder types: Other

Identifiers

NCT01611454

PREFER II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Interventional Radiologists practicing in Baptist Cardiac & Vascular Institute
• consecutive endovascular procedure requiring C-arm fluoroscopy

Exclusion criteria

• Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

XPF thyroid collar

Experimental group

Description:

Administration of the XPF Thyroid Collar during the same type of interventional radiology procedures as Comparator arm above

Treatment:

Device: XPF thyroid collar

Equivalent collar

Active Comparator group

Description:

Administration of the Standard 0.5mm lead-equivalent thyroid collar during the same type of interventional radiology procedures as Comparator arm above.

Treatment:

Device: Standard 0.5mm lead equivalent thyroid collar