New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)

NCT01450969 | Completed

• 1 other identifier: 11-052
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exposure

Keywords

Operator Comfort Assessment; Radiation protection; Measurement of Radiation Exposure; Endovascular Interventional Radiology

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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

Study Arms (1)

Interventional Radiologists

All operators are Interventional Radiologists and co-investigators. Prior to start of the study, all operators are asked to provide written informed consent to participate in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All operators are Interventional Radiologists and Co-Investigators. Prior to start of the study, all operators are asked to provide written informed consent to participate in the study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baptist Health South Florida: lead

Study Sites (1)

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Study Officials

• Barry T. Katzen, MD

  Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute

  PRINCIPAL INVESTIGATOR

• Heiko Uthoff, MD

  Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Clinical Research & Outcomes

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 13, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

US (1)