Trials / Completed
CompletedNCT01620658
Radioprotective Light-weight Caps in the Interventional Cardiology Setting
Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- Baptist Health South Florida · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 0.5mm XPF cap | 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. |
| DEVICE | 0.3mm XPF cap | 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. |
| DEVICE | Standard cap | Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2014-03-01
- Completion
- 2014-04-01
- First posted
- 2012-06-15
- Last updated
- 2022-03-07
- Results posted
- 2021-10-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01620658. Inclusion in this directory is not an endorsement.