At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison Of Effective Radiation Shielding Between A Portable, Configurable, Floor-Supported Radiation Protection System vs Conventional Apron And Shields In Clinical Interventional Procedures
In Brief
A clinical study evaluating Rampart IC, M1128, Lead Apron and Ancillary Shield, and 1 other intervention for Radiation Exposure. Completed, enrolled 63 participants across 1 site.
Detailed Summary
Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons. This single-center, randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 radiation protection system in order to improve radiation safety with minimal orthopedic strain by using the RAMPART device. There will be three study arms, each arm requiring 21 procedures for a total of 63 total procedures, Each procedure will be randomized, instead of individual subjects. Each enrolled subject may be involved in more than one procedure/case. Randomization stratification will be 1:1:1 to either Rampart shield only, lead apron and ancillary shield, or lead apron and Rampart Shield. Real-time dosimeters will be used in each procedure to measure radiation attenuation.
Study Details
Timeline
Interventions
Rampart IC, M1128 aims to address the challenge of radiation protection in the cardiac catheterization laboratory without the burden of wearing a heavy lead apron. Rampart M1128 is a compactly designed, portable, fully adjustable system that provides radiation protection for interventionalists and their technicians. It has independently adjustable flexible panels, allowing interventionalists multiple vascular access points, including right radial, bi-lateral femoral, and bi-lateral pedal. Participants in this arm will conduct catherization procedures using only the Rampart System, and radiation exposure will be measured using real-time dosimeters.
Participating providers in this arm will use conventional skirt and vest, thyroid collar, and 100% use of 2 types of ancillary shields. Most wrap-around skirts and vests were (0.25-0.5 mm) Pb. Thyroid shields were 0.5 mm Pb equivalent. Under the table lead x 2. Radiation exposure will be measured using real-time dosimeters.
Participating providers will use both the lead apron and the Rampart Shield. Radiation exposure will be measured using real-time dosimeters.