New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)

Exposure Clinical Trial

— PREFER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450969
• Other study ID #: 11-052
• Status: Completed
• Phase: N/A
• First received: September 28, 2011
• Last updated: September 23, 2014
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The PREFER Trial primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.

Description:

The PREFER Trial has three main objectives. The primary objective of the trial is to show how much radiation attenuation is provided by XPF 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 60 consecutive endovascular procedures requiring C-arm fluoroscopy performed at BCVI. Participants will be asked to wear an XPF cap (weighing approximately 100 grams) in every study procedure. Furthermore, 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 4 radiation detectors (TLDs, 2 attached to the cap, 2 attached to the 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: 60
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exposure

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation attenuation in percentage (%) and in absolute terms (µSv/min)	The null hypothesis is that the XPF thyroid collar is inferior to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission. The alternative hypothesis is that the XPF thyroid collar is non-inferior to the standard thyroid collar. If there is truly no difference between standard and XPF thyroid collars, then 60 patients are required to be 95% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -0.7% transmission rate and -0.013 µSv/min.	The attenuation is assessed directly after each procedure (day 1)	No
Secondary	Wearing comfort of the XPF cap and collar on a scale from 0-100.		(day 1) Operators are asked directly after each procedure to rate the wearing comfort	No