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

N/A

Waitlist Available

Led By Varinder P Singh, M.D.

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the Rampart IC, M1128, a portable device that shields medical staff from radiation without heavy aprons. It targets lab staff who often have pain from wearing lead aprons. The device works by blocking radiation with a movable shield, easing physical strain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in radiation attenuation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Rampart M1128 IC, OnlyExperimental Treatment1 Intervention

Consented providers will perform catherization procedures utilizing only the Rampart system. Radiation will be measured by dosimeters worn by the providers.

Group II: Lead Apron + Rampart IC, M1128Experimental Treatment1 Intervention

Consented providers will perform catherization procedures utilizing both lead apron and Rampart system. Radiation will be measured by dosimeters worn by the providers.

Group III: Lead Apron OnlyActive Control1 Intervention

This is the control group. Consented providers will perform catherization procedures utilizing only the lead apron and ancillary shields (lead skirt, vest, thyroid collar (all at least 0.5mm Pb) with use of under table lead per lab operating policy and mobile suspended lead-acrylic shield and lead glasses). Radiation will be measured by dosimeters worn by the providers.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rampart IC, M1128 and Lead Apron

2022

N/A

~70

Rampart IC, M1128

2022

N/A

~70