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3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair
Sponsor: The Cleveland Clinic
Summary
This is an Early Feasibility Study to evaluate the usability, safety and functionality of 3D holographic guidance, navigation, and control (3D-GNC) as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.
Official title: 3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3
Start Date
2023-10-18
Completion Date
2025-12-31
Last Updated
2025-04-18
Healthy Volunteers
No
Conditions
Interventions
3D Holographic Guidance, Navigation, and Control (3D GN&C)
Using electromagnetic (EM) guidance and tracking to precisely place a Cook Zenith Flex AAA bifurcated stent graft during EVAR. EM guidance and tracking is enabled using a system consisting of: 1. experimental 3D guidance, navigation, and control (3D-GNC) software developed by Centerline Biomedical, Inc., integrated with the company's FDA-cleared Intra-Operative Positioning System (IOPS), 2. FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex delivery system, and 3. 3D visualization on the IOPS mobile cart monitor and 3D holographic visualization overlaid on the patient during the procedure using a head mounted display (HMD), the Microsoft HoloLens 2.
Locations (1)
Cleveland Clinic
Cleveland, Ohio, United States