3D Holographic Surgery Assistance for Aortic Aneurysm

(3D-GN&C Trial)

Overseen By Francis Caputo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Electronic implants, Metallic implants, Systemic infection, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of 3D holographic technology to guide doctors during surgery on aortic aneurysms, which are dangerous bulges in the main blood vessel carrying blood from the heart. The goal is to determine if this 3D guidance system, known as 3D GN&C, can enhance the safety and effectiveness of surgery when used alongside regular imaging methods. Suitable candidates for this trial are those needing a specific type of surgery to repair an abdominal aortic aneurysm and who can access the required medical devices. As an unphased trial, this study allows patients to contribute to innovative surgical advancements that could improve future treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this 3D holographic guidance is safe for aortic aneurysm surgery?

Research has shown that using 3D guidance and control in medical procedures could improve results. For example, similar technology, such as 3D ultrasound, has proven effective in tracking and measuring conditions like abdominal aortic aneurysms. This suggests that 3D imaging can be both accurate and useful.

However, specific information about the safety of 3D guidance and control in humans remains limited. As this is an early feasibility study, the researchers are still testing the technology's effectiveness and safety.

New technologies like this undergo careful safety monitoring. Researchers closely observe participants for any problems, managing potential risks. The main goal is to ensure safety while assessing the technology's usefulness in surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 3D holographic surgery assistance for aortic aneurysms because it offers a new way to enhance precision during procedures. Unlike traditional methods that rely solely on fluoroscopic imaging, this approach incorporates electromagnetic guidance and tracking, which can provide surgeons with a more detailed, three-dimensional view of the anatomy. This could lead to increased accuracy and safety when placing devices like the Cook Zenith Flex AAA Endovascular Graft. By improving visualization, this technique has the potential to reduce complications and improve outcomes for patients undergoing aortic aneurysm repair.

What evidence suggests that 3D GN&C is effective for aortic aneurysm surgery?

Research has shown that 3D technology can greatly improve the accuracy of procedures for aortic aneurysms. One study found that three-dimensional ultrasound reduced the chance of missing a problem from 30% to just 6%, indicating it is much better at spotting issues. Another study demonstrated that 3D models helped doctors plan surgeries for aortic aneurysms more precisely. In this trial, participants will receive 3D holographic guidance alongside standard imaging techniques, potentially serving as a valuable tool in assisting surgeries for aortic aneurysms. ^{2 3 6 7 8}

Who Is on the Research Team?

Francis Caputo, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Electromagnetic guidance and tracking used to place Cook Zenith Flex AAA bifurcated stent graft

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D GN&C

Trial Overview The 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Thromboembolic events are the most common adverse occurrences in endovascular neurosurgery, with incidence rates varying from 2% to 61%, highlighting the need for effective prevention strategies, although optimal use of anticoagulants remains unclear.

Groin-site hematomas are the most frequent access-related complications, with an incidence of 9% to 32%, and there is a lack of standardized protocols for prevention, indicating a need for systematic guidelines to improve safety in neurosurgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in neurosurgical adverse events: endovascular neurosurgery. Wong, JM., Ziewacz, JE., Panchmatia, JR., et al.[2012]

Citations

1. nature.com nature.com/articles/s41598-017-00644-4

Precise treatment of aortic aneurysm by three-dimensional ... In this study, three-dimensional printing (3Dp) models and simulation surgeries (SSs) were applied in two challenging aortic cases.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10598132/

3D-Ultrasound Based Mechanical and Geometrical ... In this study, we present a fully ultrasound-based and automated analysis of the 3D geometrical and mechanical parameters of abdominal aortic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0741521421006765

Three-dimensional ultrasound improves identification of ... We found a fivefold decrease in the risk of false-negative results from 30% with 2D-US alone to 6% with the addition of 3D-US (P < .05). •. Take Home Message: ...

4. jvascsurg.org jvascsurg.org/article/S0741-5214(21)00334-7/fulltext

Three-dimensional ultrasound is a reliable alternative in ... The aim of the present study was, in a clinical, multicenter setting, to evaluate the accuracy of 3D-US with aneurysm model quantification ...

5. trialx.com trialx.com/clinical-trials/listings/273564/3d-ultrasound-of-abdominal-aortic-aneurysm-characteristics/

3D Ultrasound of Abdominal Aortic Aneurysm Characteristics Clinical trial for Abdominal Aortic Aneurysm , 3D Ultrasound of Abdominal Aortic Aneurysm Characteristics.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11814437/

Application of three-dimensional printing in the planning and ... This review examines the application of 3D printing and AI in complex aortic aneurysm repair, highlighting current clinical trends.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0041624X24000465

Increasing abdominal aortic aneurysm curvature visibility ... This study demonstrates the vast improvements in field of view and AAA wall visibility that a large, sparsely populated 3D array can potentially achieve.

8. nature.com nature.com/articles/s41598-021-96512-3

Geometric and biomechanical modeling aided by machine ... An artificial intelligence based abdominal aortic aneurysm prognosis classifier to predict patient outcomes. Article Open access 09 February ...