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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XPF thyroid collar | Experimental | Administration of the XPF Thyroid Collar during the same type of interventional radiology procedures as Comparator arm above |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XPF thyroid collar | Device | Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wearing Comfort of the Collar on a Scale From 0-100. | 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. | 1 day |
| Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19341885 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | XPF Thyroid Collar | Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions. |
| FG001 | Equivalent Collar | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | XPF Thyroid Collar | Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions. |
| BG001 | Equivalent Collar |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage change | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XPF Thyroid Collar | Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raul Herrera, MD. Director Miami Cardiac and Vascular Institute | Baptist Health South Florida | 786-596-3505 | raulh@baptisthealth.net |
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| Standard 0.5mm lead equivalent thyroid collar | 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. |
|
(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. |
| 1 day |
| Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps | (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. | 1 day |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Administration of the XPF Thyroid Collar. XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions. |
| OG001 | Equivalent Collar | 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. |
|
|
| Secondary | Wearing Comfort of the Collar on a Scale From 0-100. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
|
|
| Secondary | Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars | (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. | 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. | Posted | Mean | Standard Deviation | Gy | 1 day |
|
|
|
| Secondary | Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps | (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. | 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. | Posted | Mean | Standard Deviation | Gy | 1 day |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Equivalent Collar | 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. | 0 | 48 | 0 | 48 | 0 | 48 |
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