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Completed

NCT Number: NCT01450969

New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Radiation attenuation in percentage (%) and in absolute terms (μSv/min)

    Time frame: The attenuation is assessed directly after each procedure (day 1)

    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.

Secondary outcomes

  1. Wearing comfort of the XPF cap and collar on a scale from 0-100.

    Time frame: (day 1) Operators are asked directly after each procedure to rate the wearing comfort

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Registry information

Official study title

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

Acronym: PREFER

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2011
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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