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Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
An Investigator initiated, prospective, randomized, multi-site study to evaluate the clinical utility of radiation exposure reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Lead Apron and Shields | No Intervention | These procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases. | |
| Rampart IC System | Active Comparator | The study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rampart IC System | Device | RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) is a radiation protection system that the study team will use during peripheral cases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. | The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. The two methods being compared are traditional lead aprons and shields and the RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases. | Intraprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge. | The secondary endpoint will be to compare radiation exposure on a per body segment analysis on the care team using a Raysafe i3 dosimeter badge. The investigators will compare traditional lead aprons and ancillary shields to the RAMPART IC System with optional lead aprons. | Intraprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Ostergren | Contact | 469-814-4181 | bonnie.ostergren@bswhealth.org | |
| Sarah Hale | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White The Heart Hospital- Plano | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19214981 | Background | Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801. | |
| Background | Occ Med. 2010;60(6):464-9 | ||
| Background | Circulation: Cardiovascular Interventions. 2016,Volume: 9, Issue: 4, DOI: 10.1161/CIRCINTERVENTIONS.115.003273 |
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