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Holographic navigation could make aortic surgery safer

NCT ID NCT06008613

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early feasibility study tested a 3D holographic guidance system to help surgeons place stent grafts during endovascular aortic repair (EVAR) for abdominal aortic aneurysms. Two patients participated, and the system was used alongside standard X-ray imaging to confirm correct placement. The goal was to see if the holographic guidance could improve precision and reduce reliance on radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
3D holographic guidance, navigation, and control (3D-GN&C) device
What this could lead to
If successful, this technology could make aortic aneurysm repair more precise and reduce the need for X-ray imaging during surgery.
What could go wrong
This was a very small early study with only 2 participants, so results may not apply to all patients. The device is experimental and requires further testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The patient meets the instructions for use (IFU) for the 24-28 mm body Cook Zenith Flex AAA bifurcated stent graft. 1. Adequate iliac/femoral access compatible with the required introduction system 2. Non aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: i. With a length of at least 15mm ii. With a diameter measured outer wall to outer wall of no greater than 26mm and no less than 20mm iii. With an angle less than 60 degrees relative to the long access of the aneurysm and iv. With an angle less than 45 degrees relative to the axis of the suprarenal aorta c. Iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outerwall to outerwall). 2. Male/female, aged ≥ 18 3. Patient fulfilling criteria for needing endovascular repair of abdominal aortic aneurysm according to routine clinical practice criteria of the participating center 4. Women of childbearing potential must be non-pregnant, non-lactating, and not planning to become pregnant during the course of the trial; and have a negative urine or serum pregnancy test within 7 days prior to index procedure 5. Provide written informed consent as applicable and defined by site country regulation 6. Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Contraindications for Cook Zenith Flex Aortic endograft: 1. Patients with known sensitivities or allergies to stainless steel, polyester, solder (tin, silver), polypropylene, or gold 2. Patients with a systemic infection who may be at increased risk of endovascular graft infection 2. Presence of electronic implants, e.g., cardiac pacemaker, automatic implantable cardioverter/defibrillator (AICD) or nerve stimulator 3. Presence of metallic implants above the knee, e.g., artificial hip 4. Patients not willing or able to give informed consent 5. Pregnant women 6. Patients' inability to have a contrasted CT scan 7. Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation; 8. 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 9. Anatomy outside of the IFU for a 24-28 mm Cook Zenith Flex AAA bifurcated stent graft

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.