CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 197 enrolled
Drug / intervention
0.5mm XPF cap +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01620658
NCT01620658N/ACompleted
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Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial

Baptist Health South Florida·interventional·Posted Jun 15, 2012·Updated Mar 7, 2022

In Brief

A clinical study evaluating 0.5mm XPF cap, 0.3mm XPF cap, and 1 other intervention for Occupational Exposure to Radiation. Completed, enrolled 197 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOccupational Exposure to Radiation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 15, 2012
Enrollment StartAug 1, 2012
Primary CompletionMar 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.0 years ago

Interventions

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.