Rampart IC System for Radiation Shielding

(SECURE Trial)

This trial tests a new method to protect the medical team from radiation during certain procedures. The goal is to determine if the Rampart IC System, a radiation shielding device, reduces radiation exposure more effectively than traditional lead aprons and shields. It is ideal for healthcare workers involved in planned procedures using the femoral artery, particularly when working on areas at or beyond the iliac artery in the legs. The trial aims to enhance safety for those who perform these procedures regularly. As an unphased trial, it provides a unique opportunity to advance safety for healthcare professionals.

The trial information does not specify whether you need to stop taking your current medications.

Research has shown that the Rampart IC System is very safe when used correctly. Studies have found that it effectively lowers radiation exposure, providing a major safety benefit. In earlier studies with a small group of participants, it proved to be a safe way to shield against radiation, even without lead aprons. This means it protects people from unnecessary radiation without causing harm.

Researchers are excited about the Rampart IC System because it offers innovative radiation shielding without relying solely on the heavy lead aprons traditionally used. Unlike standard lead aprons, which can be cumbersome and uncomfortable, the Rampart IC System uses a combination of components like Guardian, Bunker, Shadow, and Sentry to provide flexible and effective protection. This system not only aims to reduce the physical strain on medical staff but also promises enhanced radiation protection, making it a potentially game-changing option in medical environments where radiation exposure is a concern.

Studies have shown that the Rampart IC System significantly reduces radiation exposure during medical procedures. In this trial, some participants will use the Rampart IC System, which research has demonstrated lowers radiation exposure for medical staff, enhancing safety without the need for heavy lead aprons. Research indicates that this system offers better protection for the head and neck from radiation than traditional lead shields. Specifically, the average radiation dose to operators decreased from 137 μSv/hr to just 19 μSv/hr with Rampart. This evidence suggests that the Rampart IC System provides strong radiation protection. Meanwhile, other participants in this trial will use traditional lead aprons and shields, allowing for a direct comparison of the two methods.²³⁶⁷⁸