80
Participants
Start Date
January 20, 2025
Primary Completion Date
September 8, 2025
Study Completion Date
November 3, 2025
Intra-Operative Positioning System (IOPS)
This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the use of contrast dye and radiation exposure for patients and healthcare professionals alike. IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy. During the intervention, the IOPS devices can be visualized with on-screen image guidance. The console is operated by a technician under a physician's instruction. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed.
Conventional group
This group will be treated using standardised materials (wires, catheters) during EVAR.
Clinical Center of Serbia, Belgrade
Lead Sponsor
Collaborators (1)
Centerline Biomedical, Inc.
INDUSTRY
Clinical Centre of Serbia
OTHER