RadFree Study 1.1
Research type
Research Study
Full title
RadFree Study
IRAS ID
344998
Contact name
Bijan Modarai
Contact email
Sponsor organisation
Philips Medical Systems Nederland B.V.
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The main purpose of the RadFree study is to determine whether the upgraded use of LumiGuide during navigation in endovascular treatment leads to reduced radiation in comparison to conventional fluoroscopic imaging anatomy in 2D.
The main function of the LumiGuide is that it visualizes the real-time 3D shape of endovascular devices in the context of the patient's anatomy using Fiber Optic RealShape (FORS) technology during endovascular procedures of the peripheral aortic and aortic side branch vasculatures.
The disadvantage of conventional X-ray imaging is that it can only visualize objects in 2D, leading to more radiation and procedure times for both the subject and the physician.
Subjects will be over 18 and undergoing or whose physician recommends an endovascular treatment (dilated blood vessels (aneurism) or impaired blood flow in blood vessels). We will collect patient data used within the standard of care therapy during endovascular procedures using the FORS-based image guidance and X-ray guidance related, but not limited to, radiation exposure and procedure time.
The sites selected are from different geographical regions (EU, UK, and USA) with different clinical practices.The study duration will be approximately 1 year. Subjects will be undergoing an endovascular procedure for a Fenestrated Endovascular Aortic Repair (FEVAR).
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0873
Date of REC Opinion
22 Jan 2025
REC opinion
Further Information Favourable Opinion