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

• Sponsor: Baptist Health South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01611454
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 35.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Occupational Exposure to Radiation	Device: XPF thyroid collar; Device: Standard 0.5mm lead equivalent thyroid collar	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XPF thyroid collar Administration of the XPF Thyroid Collar during the same type of interventional radiology procedures as Comparator arm above	Device: XPF thyroid collar; Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.
Active Comparator: Equivalent collar 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; 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.

Outcome Measures

Primary Outcome Measures

1. Percentage Change [1 day]

   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.

Secondary Outcome Measures

1. Wearing Comfort of the Collar on a Scale From 0-100. [1 day]

   Operators are asked directly after each procedure to rate the wearing comfort, graded worst to best. 0 means low comfort (worse outcome) and 100 is the best comfort level (best outcome) with wearing the collar.

2. Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars [1 day]

   (day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors (TLDs, 2 attached to the collar) which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue.

3. Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps [1 day]

   (day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raul Herrera, MD, Director, Division of Clinical Research & Outcomes, Baptist Health South Florida
• ClinicalTrials.gov Identifier: NCT01611454
• Other Study ID Numbers: PREFER II
• First Posted: Jun 5, 2012
• Last Update Posted: Nov 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Raul Herrera, MD, Director, Division of Clinical Research & Outcomes, Baptist Health South Florida: Occupational Exposure to Radiation

Study Results

Participant Flow

Arm/Group Title	XPF Thyroid Collar	Equivalent Collar
Arm/Group Description	Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.	Administration of the Standard 0.5mm lead-equivalent thyroid collar. Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions.
Period Title: Overall Study
STARTED	58	48
COMPLETED	40	38
NOT COMPLETED	18	10

Baseline Characteristics

Arm/Group Title	XPF Thyroid Collar	Equivalent Collar	Total
Arm/Group Description	Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.	Administration of the Standard 0.5mm lead-equivalent thyroid collar. Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions.	Total of all reporting groups
Overall Participants	58	48	106
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	36 62.1%	26 54.2%	62 58.5%
>=65 years	22 37.9%	22 45.8%	44 41.5%
Age (Year) [Median (Standard Deviation) ]
Median (Standard Deviation) [Year]	50 (25)	50 (25)	50 (25)
Sex: Female, Male (Count of Participants)
Female	26 44.8%	24 50%	50 47.2%
Male	32 55.2%	24 50%	56 52.8%
Region of Enrollment (participants) [Number]
United States	58 100%	48 100%	106 100%

Outcome Measures

1. Primary Outcome

Title	Percentage Change
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XPF Thyroid Collar	Equivalent Collar
Arm/Group Description	Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.	Administration of the Standard 0.5mm lead-equivalent thyroid collar. Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions.
Measure Participants	58	48
Mean (Standard Deviation) [percentage change]	79.7 (25.8)	71.9 (34.2)

2. Secondary Outcome

Title	Wearing Comfort of the Collar on a Scale From 0-100.
Description	Operators are asked directly after each procedure to rate the wearing comfort, graded worst to best. 0 means low comfort (worse outcome) and 100 is the best comfort level (best outcome) with wearing the collar.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XPF Thyroid Collar	Equivalent Collar
Arm/Group Description	Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.	Administration of the Standard 0.5mm lead-equivalent thyroid collar. Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions.
Measure Participants	58	48
Mean (Standard Deviation) [score on a scale]	85.0 (8.8)	83.3 (13.1)

3. Secondary Outcome

Title	Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars
Description	(day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors (TLDs, 2 attached to the collar) which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

XPF thyroid collar and the equivalent collar are combined under one outcome measure as the outcome measure is comparing the arms and not as individual measures.

Arm/Group Title	Dose Measured Outside Collar	Dose Measured Inside Collar
Arm/Group Description	Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. It will be measured based on uSv's.	Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. It will be measured based on uSv's.
Measure Participants	106	106
Mean (Standard Deviation) [Gy]	272.3 (373.3)	98.2 (203.1)

4. Secondary Outcome

Title	Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps
Description	(day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

XPF caps and the equivalent caps are combined under one outcome measure as the outcome measure is comparing the arms and not as individual measures.

Arm/Group Title	Dose Measured Outside Cap	Dose Measured Inside Cap
Arm/Group Description	Radiation exposure will be monitored with radiation detectors outside the cap, which the participant is required to wear. It will be measured based on uSv's.	Radiation exposure will be monitored with radiation detectors inside the cap, which the participant is required to wear. It will be measured based on uSv's.
Measure Participants	106	106
Mean (Standard Deviation) [Gy]	224.1 (266.1)	48.1 (124.7)

Adverse Events

Arm/Group Title	XPF Thyroid Collar		Equivalent Collar
Arm/Group Description	Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.		Administration of the Standard 0.5mm lead-equivalent thyroid collar. Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions.
All Cause Mortality
	XPF Thyroid Collar		Equivalent Collar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/48 (0%)
Serious Adverse Events
	XPF Thyroid Collar		Equivalent Collar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	XPF Thyroid Collar		Equivalent Collar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.