Comparison Of Effective Radiation Shielding Between Rampart IC, M1128 Shield vs Conventional Apron And Shields In Clinical Interventional Procedures

NACompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

March 9, 2022

Primary Completion Date

December 9, 2022

Study Completion Date

December 9, 2022

Conditions
Radiation Exposure
Interventions
DEVICE

Rampart IC, M1128

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.

DEVICE

Lead Apron and Ancillary Shield

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.

DEVICE

Rampart IC, M1128 and Lead Apron

Participating providers will use both the lead apron and the Rampart Shield. Radiation exposure will be measured using real-time dosimeters.

Trial Locations (1)

10075

Lenox Hill Hospital, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER

NCT05347290 - Comparison Of Effective Radiation Shielding Between Rampart IC, M1128 Shield vs Conventional Apron And Shields In Clinical Interventional Procedures | Biotech Hunter | Biotech Hunter