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ACTIVE NOT RECRUITING
NCT06008613
NA

3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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

Interventions

DEVICE

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