Clinical trial NCT01450969: New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)
Official title: Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure
Keywords: Operator Comfort Assessment
Radiation protection
Measurement of Radiation Exposure
Endovascular Interventional Radiology
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Radiation attenuation in percentage (%) and in absolute terms (μSv/min)
timeFrame: The attenuation is assessed directly after each procedure (day 1)
Secondary outcomes:
measure: Wearing comfort of the XPF cap and collar on a scale from 0-100.
timeFrame: (day 1) Operators are asked directly after each procedure to rate the wearing comfort
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
state: Florida
Study officials:
affiliation: Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
name: Barry T. Katzen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
name: Heiko Uthoff, MD
role: PRINCIPAL_INVESTIGATOR
References: