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Completed

NCT Number: NCT01620658

Radioprotective Light-weight Caps in the Interventional Cardiology Setting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.5mm XPF cap

Device

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 cap

Device

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 cap

Device

Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Registry information

Official study title

Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial

Acronym: PROTECT

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 15, 2012
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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