New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)

NCT ID: NCT01450969

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Exposure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baptist Health South Florida

OTHER

Sponsor Role: lead

Responsible Party

Raul Herrera, MD

Director, Division of Clinical Research & Outcomes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry T. Katzen, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute

Heiko Uthoff, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute

Locations

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, United States

Countries

United States

Other Identifiers

11-052

Identifier Type: -

Identifier Source: org_study_id