NCT06008613

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

3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of this clinical study is to evaluate the feasibility of 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 the following: 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. Planning and execution of each case will be major steps in demonstrating feasibility of the technology beyond non-clinical and preclinical testing.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-18
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-08-23
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study