3D Holographic Surgery Assistance for Aortic Aneurysm
(3D-GN&C Trial)

Recruiting in Palo Alto (17 mi)

Overseen byFrancis Caputo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Cleveland Clinic

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new technology that uses 3D holograms and sensors to help doctors place stents more accurately in patients undergoing a specific type of blood vessel repair. The goal is to make the procedure safer and more precise.

Research Team

Francis Caputo, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

Adults who need endovascular repair for abdominal aortic aneurysm and fit the specific size criteria for the Cook Zenith Flex AAA stent graft can join. Women must not be pregnant or planning pregnancy. Participants should agree to all study procedures, have no allergies to stent materials, no systemic infections, and no electronic or metallic implants above the knee.

Inclusion Criteria

I need a procedure for my abdominal aortic aneurysm as per my doctor's advice.

My veins are suitable for the necessary medical procedure.

I am not pregnant, breastfeeding, or planning to become pregnant, and I had a negative pregnancy test recently.

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Exclusion Criteria

The anatomy does not fit the instructions for use for a specific stent graft.

I cannot have a CT scan with contrast.

Other medical, social, or psychological issues that in the opinion of the investigator preclude the subjects from receiving this treatment, and the procedures and evaluations pre- and posttreatment

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Treatment Details

Interventions

3D GN&C (Procedure)

Trial OverviewThe trial is testing a new technology called 3D GN&C as an add-on tool during surgery with Cook Zenith Flex AAA Endovascular Graft. It aims to improve navigation and placement of the graft in patients with abdominal aortic aneurysms.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Electromagnetic guidance and tracking as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.