Rampart IC, M1128 for nuclear radiation emergency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lenox Hill Hospital, New York, NY
nuclear radiation emergency
Rampart IC, M1128 - Device
Eligibility
18+
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 90 days

90 days
Change in radiation attenuation

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Lead Apron Only
1 of 3
Rampart M1128 IC, Only
1 of 3
Lead Apron + Rampart IC, M1128
1 of 3
Active Control
Experimental Treatment

63 Total Participants · 3 Treatment Groups

Primary Treatment: Rampart IC, M1128 · No Placebo Group · N/A

Rampart M1128 IC, Only
Device
Experimental Group · 1 Intervention: Rampart IC, M1128 · Intervention Types: Device
Lead Apron + Rampart IC, M1128
Device
Experimental Group · 1 Intervention: Rampart IC, M1128 and Lead Apron · Intervention Types: Device
Lead Apron Only
Device
ActiveComparator Group · 1 Intervention: Lead Apron and Ancillary Shield · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
Closest Location: Lenox Hill Hospital · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2003First Recorded Clinical Trial
1 TrialsResearching nuclear radiation emergency
88 CompletedClinical Trials

Who is running the clinical trial?

Northwell HealthLead Sponsor
409 Previous Clinical Trials
290,147 Total Patients Enrolled
Varinder P Singh, M.D.Principal InvestigatorSenior Vice President, Cardiology

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are scheduled to work in Room C of the cardiac catheterization laboratory.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References