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New device aims to make brain aneurysm coiling safer

NCT ID NCT04518670

Disease control Sponsor: Rapid Medical Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a temporary device called Comaneci that helps doctors place coils in wide-necked brain aneurysms. 90 patients were treated and followed for up to 6 months to check safety and how well the aneurysm was sealed. The goal was to see if the device works well in everyday hospital use.

What this could mean

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

Active substance
Comaneci Embolization Assist Device
What this could lead to
If successful, this device could offer a safer way to treat wide-necked brain aneurysms without open surgery.
What could go wrong
This is a small, completed surveillance study, not a large randomized trial. Results may not apply to all aneurysm types or patients.

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.

Participants

90 people

The number who actually took part.

Started

Nov 2020

Finished

Jul 2024

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.

Who is studied

The Postmarket Sureveillance Study will include male or female patients with wide-necked ruptured and/or unruptured intracranial aneurysms that may require adjunctive assistance with coil embolization during the surgical procedure.

Ages

18 to 85 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 has a documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils. 2. Patient is considered for treatment with coil embolization assisted by the Comaneci Device for wide-necked intracranial aneurysms with neck width ≤ 10 mm. A wide-necked intracranial aneurysm is defined by the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2. 3. A signed informed consent by the patient or legally authorized representative Exclusion Criteria: 1\. Patient with known hypersensitivity to nickel-titanium

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Conditions

The condition(s) this trial relates to.

Aneurysm brain aneurysm

As listed by the trial registrant

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

Intracranial aneurysm

Contacts and locations

Locations

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207, United States

  • Carondelet St. Joseph's Hospital (Tenet)

    Tucson, Arizona, 85711, United States

  • Los Robles

    Thousand Oaks, California, 91360, United States

  • Santa Barbara Cottage

    Santa Barbara, California, 93105, United States

  • St. Mary's Medical Ctr (Tenet)

    West Palm Beach, Florida, 33407, United States

  • Texas Stroke Institute (Sarah Cannon TN)

    Dallas, Texas, 75075, United States

  • USA Health University Hospital

    Mobile, Alabama, 36617, United States

  • University of Buffalo

    Buffalo, New York, 14203, United States

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