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Experimental device aims to seal brain aneurysms without surgery

NCT ID NCT07117526

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new, experimental device called the HARBOR Occlusion Device for treating brain aneurysms. Ten adults with a single unruptured brain aneurysm will receive the device to see if it safely and effectively blocks blood flow to the aneurysm. The goal is to prevent future bleeding without needing additional treatments.

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 79 years

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. Patient must be 18-79 years of age at the time of screening. 2. Patient must have a single unruptured IA requiring treatment. If the subject has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure. 3. The index IA to be treated must have the following characteristics: 1. Saccular in shape 2. Diameter 2.5 mm to 12.0 mm 3. IA is appropriate for treatment with the HARBOR Occlusion Device per device Instructions for Use 4. Patient has an IA that is appropriate for treatment with HARBOR Occlusion Device without the use of additional implanted devices 5. Patient must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule. Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures. 6. Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures. Exclusion Criteria: 1. Patient has a ruptured IA, defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 180 days. 2. Patient has an IA with characteristics unsuitable for endovascular treatment. 3. Microcatheter could not reach patient's index aneurysm to allow necessary access to treat with study device. 4. Patient has vessel characteristics, tortuosity or morphology which could preclude safe access and support during treatment with study device; 5. Patient has vascular disease or other vascular anomaly so as to preclude the necessary access to the aneurysm for use of the study device. 6. Patient has clinical, angiographic or CT evidence of vasospasm, vasculitis, or intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation. 7. Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60 days. 8. Patient has any circulatory, neurovascular, cardiovascular, or neurologic conditions that have resulted in unstable neurological symptoms. 9. Patient has mRS ≥ 2 prior to presentation 10. Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 180 days. 11. Patient has physical, neurologic or psychiatric conditions which preclude his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule. 12. Patient has a known blood dyscrasia, coagulopathy, or hemoglobinopathy. 13. Patient is pregnant. 14. Patient has known hypersensitivity, which cannot be medically treated, to any component of the study implant device (primarily nickel-titanium alloy), procedural materials, or medications commonly used during the procedure. 15. Patient is concurrently involved in another investigational study or a post-market study that could affect the safety and effectiveness of IA treatment with the study device or with the study's follow-up schedule. 16. Patient has an acute life-threatening illness other than the neurological disease to be treated in this trial. 17. Patient has a life expectancy of less than 2 years due to other illness or condition (in addition to an intracranial aneurysm).

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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

  • University Hospital St. Ivan Rilski

    Sofia, Bulgaria