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

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ClinicalTrials.gov Identifier: NCT01611454
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Raul Herrera, MD, Baptist Health South Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Occupational Exposure to Radiation Device: XPF thyroid collar Device: Standard 0.5mm lead equivalent thyroid collar Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)
Study Start Date : May 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: XPF thyroid collar
Administration of the XPF Thyroid Collar.
Device: XPF thyroid collar
Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.

Active Comparator: Equivalent collar
Administration of the Standard 0.5mm lead-equivalent thyroid collar.
Device: Standard 0.5mm lead equivalent thyroid collar
Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions.




Primary Outcome Measures :
  1. Radiation attenuation in percentage (%) [ Time Frame: 1 day ]
    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%.


Secondary Outcome Measures :
  1. Wearing comfort of the collar on a scale from 0-100. [ Time Frame: 1 day ]
    Operators are asked directly after each procedure to rate the wearing comfort

  2. Radiation attenuation in absolute terms (uSv) [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611454


Locations
United States, Florida
Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
Sponsors and Collaborators
Baptist Health South Florida
Investigators
Principal Investigator: Barry T Katzen, MD Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
Principal Investigator: Heiko Uthoff, MD Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

Responsible Party: Raul Herrera, MD, Director, Division of Clinical Research & Outcomes, Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT01611454     History of Changes
Other Study ID Numbers: PREFER II
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Raul Herrera, MD, Baptist Health South Florida:
Occupational Exposure to Radiation