- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620658
Radioprotective Light-weight Caps in the Interventional Cardiology Setting (PROTECT)
Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Miami, Florida, United States, 33176
- Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Interventional Cardiologist practicing in Baptist Cardiac & Vascular Institute
- cardiac procedure requiring C-arm fluoroscopy
Exclusion Criteria:
- Interventional Neuroradiologists and Interventional Radiologists will not be included in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: standard cap
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
|
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
|
EXPERIMENTAL: 0.3mm XPF cap
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
|
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. |
EXPERIMENTAL: 0.5mm XPF cap
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 day
|
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.
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1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operator Comfort Assessment
Time Frame: 1 day per participant, a total of 197 operator days
|
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).
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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
|
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).
|
1 day per participant, a total of 197 operator days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raul Herrera, MD, Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PROTEcT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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