Occupational Exposure to RadiationPROTECTNCT01620658
Radioprotective Light-weight Caps in the Interventional Cardiology Setting
A study testing 0.5mm XPF cap, 0.3mm XPF cap and Standard cap in people with Occupational Exposure to Radiation, run by Baptist Health South Florida at 1 site in United States.
Trial summary
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure to Radiation
- What is being tested?
- 0.5mm XPF cap, 0.3mm XPF cap and Standard cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Interventional Cardiologist practicing in Baptist Cardiac \& Vascular Institute
- cardiac procedure requiring C-arm fluoroscopy
Who cannot join
- Interventional Neuroradiologists and Interventional Radiologists 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: Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
Read the detailed description
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
For more information please contact Dr. Raul Herrera, MD, Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami.
- Conditions
- Occupational Exposure to Radiation
- Being tested
- 0.5mm XPF cap, 0.3mm XPF cap, Standard cap
- Keywords
- Occupational Exposure to Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5mm XPF capDevice
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
0.3mm XPF capDevice
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
Standard capDevice
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
| Study group | Role | What they receive |
|---|---|---|
| standard cap | Active comparator | Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Receives: Device: Standard cap |
| 0.3mm XPF cap | Experimental | Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. Receives: Device: 0.3mm XPF cap |
| 0.5mm XPF cap | Experimental | Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. Receives: Device: 0.5mm XPF cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Attenuation in Percentage (%)
The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100.
Measured: 1 day
Absolute Radiation Exposure Outside of Cap
The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.
Measured: 1 day
Secondary outcomes (2)
Operator Comfort Assessment
After completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).
Measured: 1 day per participant, a total of 197 operator days
Operator Comfort Assessment Based on Weight
After completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).
Measured: 1 day per participant, a total of 197 operator days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational Exposure to RadiationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 197 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
- Raul Herrera, MD, Principal investigator, Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620658
- Sponsor's protocol ID
- PROTECT
- Acronym
- PROTECT
- Status last verified
- Sep 2021
- First submitted
- 6 Jun 2012
- Last updated
- 7 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Uthoff H, Quesada R, Roberts JS, Baumann F, Schernthaner M, Zaremski L, Hajirawala L, Katzen BT, Staub D, Kreusch AS. Radioprotective lightweight caps in the interventional cardiology setting: a randomised controlled trial (PROTECT). EuroIntervention. 2015 May;11(1):53-9. doi: 10.4244/EIJV11I1A9.
PubMed 25982649
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01620658
- Acronym / sponsor ID
- PROTECT / PROTECT
- Conditions
- Occupational Exposure to Radiation
- Keywords
- Occupational Exposure to Radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Posted 21 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
Detailed description
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
For more information please contact Dr. Raul Herrera, MD, Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard cap | Active comparator | Device: Standard capInterventionalist wear a standard fabric cap during fluoroscopy guided interventions. |
| 0.3mm XPF cap | Experimental | Device: 0.3mm XPF capInterventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. |
| 0.5mm XPF cap | Experimental | Device: 0.5mm XPF capInterventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Interventional Cardiologist practicing in Baptist Cardiac \& Vascular Institute
- cardiac procedure requiring C-arm fluoroscopy
Key exclusion criteria (1 listed)
- Interventional Neuroradiologists and Interventional Radiologists 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5mm XPF capInterventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. | Device | 0.5mm XPF cap |
| 0.3mm XPF capInterventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. | Device | 0.3mm XPF cap |
| Standard capInterventionalist wear a standard fabric cap during fluoroscopy guided interventions. | Device | standard cap |
Primary outcome
Radiation Attenuation in Percentage (%)
Time frame: 1 day
The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100.
Absolute Radiation Exposure Outside of Cap
Time frame: 1 day
The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.
2 secondary outcomes
Operator Comfort Assessment
Time frame: 1 day per participant, a total of 197 operator days
Operator Comfort Assessment Based on Weight
Time frame: 1 day per participant, a total of 197 operator days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25982649Uthoff H, Quesada R, Roberts JS, Baumann F, Schernthaner M, Zaremski L, Hajirawala L, Katzen BT, Staub D, Kreusch AS. Radioprotective lightweight caps in the interventional cardiology setting: a randomised controlled trial (PROTECT). EuroIntervention. 2015 May;11(1):53-9. doi: 10.4244/EIJV11I1A9.
- Individual participant dataSharing planned: No
Related trials for Occupational Exposure to Radiation
Enrolling by invitation
Personalizing Veterans' Lung Cancer Screening and Diagnosis
Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Recruiting
Exoskeleton vs. Standard Lead Apron in EVAR Procedures
Radiation Exposure to Operator, Endovascular Aortic Repair
Active, not recruitingObservational study
Epidemiological Study of Korean Radiation Workers
Occupational Exposure to Radiation, Neoplasms, Radiation-Induced
Active, not recruiting
PMT-Based Radiation Safety Training for Nurses: Randomized Controlled Trial.
Occupational Radiation Exposure in Operating Room Nurses
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.
Raul Herrera, MD principal investigator
Baptist Hospital of Miami, 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?
A study testing 0.5mm XPF cap, 0.3mm XPF cap and Standard cap in people with Occupational Exposure to Radiation, 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 7 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (%) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01620658, which also lists 1 linked publication.
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 7 Mar 2022.