Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.
Overview
Brief Summary
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Detailed Description
An Investigator initiated, prospective, randomized, multi-site study to evaluate the clinical utility of radiation exposure reduction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Member of the interventional care team
- •Elective peripheral procedure
- •The access site is the femoral artery
- •The treatment area is at or distal to the iliac artery
Exclusion Criteria
- •Individuals who are not yet adults, pregnant women, or prisoners.
- •Urgent and emergent cases
Arms & Interventions
Traditional Lead Apron and Shields
These procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases.
Rampart IC System
The study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.
Intervention: Rampart IC System (Device)
Outcomes
Primary Outcomes
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.
Time Frame: Intraprocedural
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.
Secondary Outcomes
- The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.(Intraprocedural)