Clinical trial NCT01611454: New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)
Official title: Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Exposure to Radiation
Keywords: Occupational Exposure to Radiation
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Change
timeFrame: 1 day
Secondary outcomes:
measure: Wearing Comfort of the Collar on a Scale From 0-100.
timeFrame: 1 day
measure: Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars
timeFrame: 1 day
measure: Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps
timeFrame: 1 day
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
state: Florida
Study officials:
affiliation: Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
name: Barry T Katzen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
name: Heiko Uthoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rowe VL, Lee W, Weaver FA, Etzioni D. Patterns of treatment for peripheral arterial disease in the United States: 1996-2005. J Vasc Surg. 2009 Apr;49(4):910-7. doi: 10.1016/j.jvs.2008.11.054.