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

Occupational Exposure to Radiation Clinical Trial

— PREFER-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611454
• Other study ID #: PREFER II
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2021
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Occupational Exposure to Radiation

Intervention

Device:
• XPF thyroid collar
Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.
• 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.

Locations

Country	Name	City	State
United States	Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change	Radiation attenuation. The null hypothesis is that the XPF thyroid collar is equal to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission in relative (%) terms. The alternative hypothesis is that the XPF thyroid collar is superior or inferior to the standard thyroid collar. Based on our results obtained during the 60 procedures (PREFER trial), 150 procedures are required to demonstrate a significant difference with an alpha level of 5% and a power of 80%. Radiation attenuation percentage is measure by interrogation of the lead attenuates X-rays counter required to be used in all interventional radiology clinical procedures by each physician operator. The interrogation is done by measuring the energy imparted per unit mass in the counter wore by ionizing radiation to matter at the specified point. The International System of Units (SI) unit of absorbed dose is the joule per kilogram.	1 day
Secondary	Wearing Comfort of the Collar on a Scale From 0-100.	Operators are asked directly after each procedure to rate the wearing comfort, graded worst to best. 0 means low comfort (worse outcome) and 100 is the best comfort level (best outcome) with wearing the collar.	1 day
Secondary	Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars	(day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors (TLDs, 2 attached to the collar) which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue.	1 day
Secondary	Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps	(day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue.	1 day