Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008613
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-08-09
Brief Title:
3D Holographic Guidance Navigation and Control for Endovascular Aortic Repair
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
3D Holographic Guidance Navigation and Control 3D GNC for Endovascular Aortic Repair EVAR
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3D-GNC
Brief 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 companys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R44HL139290-03 | NIH | None | httpsreporternihgovquickSearch5R44HL139290-03 |