Radiation Exposure Using Rampart vs Standard Lead Aprons and Shields During Invasive Cardiovascular Procedures.
John C Lisko, Nikoloz Shekiladze, Joseph Chamoun...
https://pubmed.ncbi.nlm.nih.gov/39131978Actively Recruiting
Led by Liverpool Heart and Chest Hospital NHS Foundation Trust · Updated on 2025-11-24
100
Participants Needed
1
Research Sites
N/A
Total Duration
L
Liverpool Heart and Chest Hospital NHS Foundation Trust
Lead Sponsor
R
Rampart Health, L.L.C.
Collaborating Sponsor
This research focuses on protecting doctors and nurses who perform heart procedures using X-ray guidance from harmful radiation exposure. Radiation exposure raises risks of cancers, eye damage like cataracts, and DNA damage. While lead protective clothing is used, it is heavy and uncomfortable, causing muscle and joint problems. The study evaluates a new device called RAMPART to see if it can better reduce radiation exposure and allow lighter or no protective gear, improving safety and comfort for medical teams. Participants will be involved in standard coronary intervention procedures using either the RAMPART radiation protection device or standard radiation protection. The study randomly assigns procedures to use RAMPART or standard protection. The device aims to reduce radiation doses to the cardiac catheter lab staff, potentially enabling them to wear lighter or no lead protection. During the study, researchers will measure radiation levels received by operators and team members, focusing on eye exposure as the primary outcome. Additional radiation measurements at the chest, groin, and overall levels for operators and nurses will be tracked. These doses will be monitored per procedure and cumulatively through about one year. The study will assess radiation safety and protective effectiveness while monitoring participant involvement throughout the trial period.
CONDITIONS
The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: The REDUCE Trial
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 year
Participants undergo coronary intervention procedures with either the RAMPART radiation protection device or standard radiation protection in the cardiac catheter lab.
Procedures occur as scheduled in the cardiac catheter lab
Total: 1 location
1
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
J
John D Hung, MBChB PhD MRCP(UK)
D
Debar Rasoul, MBChB BSc MRCP(UK)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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John C Lisko, Nikoloz Shekiladze, Joseph Chamoun...
https://pubmed.ncbi.nlm.nih.gov/39131978Husam A Noor, Noof Althawadi, Zaina Noor...
https://pubmed.ncbi.nlm.nih.gov/39350833