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

NCT01611454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-11-19

Study results available
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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.

Conditions

  • Occupational Exposure to Radiation

Interventions

DEVICE

XPF thyroid collar

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

DEVICE

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.

Sponsors & Collaborators

  • Baptist Health South Florida

    lead OTHER

Principal Investigators

  • Barry T Katzen, MD · Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

  • Heiko Uthoff, MD · Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611454 on ClinicalTrials.gov