Radiation Exposure Clinical Trial
— RAMPARTOfficial title:
Comparison Of Effective Radiation Shielding Between A Portable, Configurable, Floor-Supported Radiation Protection System vs Conventional Apron And Shields In Clinical Interventional Procedures
NCT number | NCT05347290 |
Other study ID # | 21-1302 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2022 |
Est. completion date | December 9, 2022 |
Verified date | February 2023 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | December 9, 2022 |
Est. primary completion date | December 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants > 18 years of age. - Interventional cardiology staff at Lenox Hill Hospital that are scheduled to work in Room C of the cardiac catheterization laboratory. Exclusion Criteria: - Pregnancy - Unwilling to consent to the study protocol. |
Country | Name | City | State |
---|---|---|---|
United States | Lenox Hill Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Andreassi MG, Piccaluga E, Guagliumi G, Del Greco M, Gaita F, Picano E. Occupational Health Risks in Cardiac Catheterization Laboratory Workers. Circ Cardiovasc Interv. 2016 Apr;9(4):e003273. doi: 10.1161/CIRCINTERVENTIONS.115.003273. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in radiation attenuation | Change in radiation attenuation as detected by dosimeter readings for staff assigned to each randomization stratification. | 90 days |
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