Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01620658
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
2012-06-06
Brief Title:
Radioprotective Light-weight Caps in the Interventional Cardiology Setting
Sponsor:
Baptist Health South Florida
Organization:
Baptist Health South Florida
Study Overview
Official Title:
Radioprotective Light-weight Caps in the Interventional Cardiology Setting a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT
Brief Summary:
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps 05mm lead-equivalent and 03mm 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 05mm lead-equivalent and 03mm 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
For more information please contact Dr Raul Herrera MD Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None