Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBaylor Research Institute

About this trial

Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Individuals who are not yet adults, pregnant women, or prisoners.

Urgent and emergent cases

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Traditional Lead Apron and ShieldsNo intervention 0 interventions
Group B: Rampart IC SystemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Intraprocedural

Secondary outcomes

1

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.

Time frame
Intraprocedural

Other outcomes

Sponsors and contacts

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