New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raul Herrera, MD, Baptist Health South Florida
ClinicalTrials.gov Identifier:
NCT01450969
First received: September 28, 2011
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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


Condition
Exposure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)

Resource links provided by NLM:


Further study details as provided by Baptist Health South Florida:

Primary Outcome Measures:
  • Radiation attenuation in percentage (%) and in absolute terms (μSv/min) [ Time Frame: The attenuation is assessed directly after each procedure (day 1) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450969

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
  More Information

No publications provided

Responsible Party: Raul Herrera, MD, Director, Division of Clinical Research & Outcomes, Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT01450969     History of Changes
Other Study ID Numbers: 11-052
Study First Received: September 28, 2011
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baptist Health South Florida:
Operator Comfort Assessment
Radiation protection
Measurement of Radiation Exposure
Endovascular Interventional Radiology

ClinicalTrials.gov processed this record on August 19, 2014