NCT01611454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

November 19, 2021

Completed
Last Updated

November 19, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

May 2, 2012

Results QC Date

January 26, 2015

Last Update Submit

October 25, 2021

Conditions

Occupational Exposure to Radiation

Keywords

Occupational Exposure to Radiation

Outcome Measures

Primary Outcomes (1)

  • Percentage Change

    Radiation attenuation. 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%. Radiation attenuation percentage is measure by interrogation of the lead attenuates X-rays counter required to be used in all interventional radiology clinical procedures by each physician operator. The interrogation is done by measuring the energy imparted per unit mass in the counter wore by ionizing radiation to matter at the specified point. The International System of Units (SI) unit of absorbed dose is the joule per kilogram.

    1 day

Secondary Outcomes (3)

  • Wearing Comfort of the Collar on a Scale From 0-100.

    1 day

  • Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars

    1 day

  • Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps

    1 day

Study Arms (2)

XPF thyroid collar

EXPERIMENTAL

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

Device: XPF thyroid collar

Equivalent collar

ACTIVE COMPARATOR

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

Device: Standard 0.5mm lead equivalent thyroid collar

Interventions

XPF thyroid collarDEVICE

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

XPF thyroid collar
Standard 0.5mm lead equivalent thyroid collarDEVICE

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.

Equivalent collar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Interventional Radiologists practicing in Baptist Cardiac \& Vascular Institute
  • consecutive endovascular procedure requiring C-arm fluoroscopy

You may not qualify if:

  • Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Related Publications (1)

  • 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.

    PMID: 19341885RESULT

Results Point of Contact

Title
Raul Herrera, MD. Director Miami Cardiac and Vascular Institute
Organization
Baptist Health South Florida
raulh@baptisthealth.net
786-596-3505

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Clinical Research & Outcomes

Study Record Dates

First Submitted

May 2, 2012

First Posted

June 5, 2012

Study Start

May 1, 2011

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

November 19, 2021

Results First Posted

November 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)