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

NCT ID: NCT01611454

Last Updated: 2021-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Occupational Exposure to Radiation

Keywords

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Occupational Exposure to Radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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XPF thyroid collar

Administration of the XPF Thyroid Collar during the same type of interventional radiology procedures as Comparator arm above

Group Type EXPERIMENTAL

XPF thyroid collar

Intervention Type DEVICE

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

Equivalent collar

Administration of the Standard 0.5mm lead-equivalent thyroid collar during the same type of interventional radiology procedures as Comparator arm above.

Group Type ACTIVE_COMPARATOR

Standard 0.5mm lead equivalent thyroid collar

Intervention Type DEVICE

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.

Interventions

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XPF thyroid collar

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baptist Health South Florida

OTHER

Sponsor Role lead

Responsible Party

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Raul Herrera, MD

Director, Division of Clinical Research & Outcomes

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry T Katzen, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

Heiko Uthoff, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

Locations

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Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Site Status

Countries

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United States

References

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Rowe VL, Lee W, Weaver FA, Etzioni D. Patterns of treatment for peripheral arterial disease in the United States: 1996-2005. J Vasc Surg. 2009 Apr;49(4):910-7. doi: 10.1016/j.jvs.2008.11.054.

Reference Type RESULT
PMID: 19341885 (View on PubMed)

Other Identifiers

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PREFER II

Identifier Type: -

Identifier Source: org_study_id