ExposurePREFERNCT01450969
New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)
An observational study of Exposure, run by Baptist Health South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exposure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Interventional Radiologists practicing in Baptist Cardiac \& Vascular Institute
- consecutive endovascular procedure requiring C-arm fluoroscopy
Who cannot join
- Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
Miami, Florida, 33176
About this study
Official title: Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)
The PREFER Trial primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.
Read the 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
- Keywords
- Operator Comfort Assessment, Radiation protection, Measurement of Radiation Exposure, Endovascular Interventional Radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation attenuation in percentage (%) and in absolute terms (μSv/min)
The null hypothesis is that the XPF thyroid collar is inferior to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission. The alternative hypothesis is that the XPF thyroid collar is non-inferior to the standard thyroid collar. If there is truly no difference between standard and XPF thyroid collars, then 60 patients are required to be 95% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -0.7% transmission rate and -0.013 μSv/min.
Measured: The attenuation is assessed directly after each procedure (day 1)
Secondary outcomes (1)
Wearing comfort of the XPF cap and collar on a scale from 0-100.
Measured: (day 1) Operators are asked directly after each procedure to rate the wearing comfort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Herrera, MD, Baptist Health South Florida
- Investigators
- Barry T. Katzen, MD, Principal investigator, Baptist Hospital of Miami and its Miami Cardiac and Vascular InstituteHeiko Uthoff, MD, Principal investigator, Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450969
- Sponsor's protocol ID
- 11-052
- Acronym
- PREFER
- Status last verified
- Sep 2014
- First submitted
- 28 Sep 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of a New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)
- ClinicalTrials.gov ID
- NCT01450969
- Acronym / sponsor ID
- PREFER / 11-052
- Conditions
- Exposure
- Keywords
- Operator Comfort Assessment, Radiation protection, Measurement of Radiation Exposure, Endovascular Interventional Radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Interventional Radiologists practicing in Baptist Cardiac \& Vascular Institute
- consecutive endovascular procedure requiring C-arm fluoroscopy
Key exclusion criteria (1 listed)
- Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiation attenuation in percentage (%) and in absolute terms (μSv/min)
Time frame: The attenuation is assessed directly after each procedure (day 1)
The null hypothesis is that the XPF thyroid collar is inferior to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission. The alternative hypothesis is that the XPF thyroid collar is non-inferior to the standard thyroid collar. If there is truly no difference between standard and XPF thyroid collars, then 60 patients are required to be 95% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -0.7% transmission rate and -0.013 μSv/min.
1 secondary outcome
Wearing comfort of the XPF cap and collar on a scale from 0-100.
Time frame: (day 1) Operators are asked directly after each procedure to rate the wearing comfort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry T. Katzen, MD principal investigator
Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
Heiko Uthoff, MD principal investigator
Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure, run by Baptist Health South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation attenuation in percentage (%) and in absolute terms (μSv/min) (time frame: The attenuation is assessed directly after each procedure (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.