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Soft brain probe tested in humans for first time

NCT ID NCT06673264

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This first-in-human study tested a new soft neural probe in 5 adults already scheduled for brain surgery to remove a tumor or epileptic tissue. The probe was inserted into the part of the brain being removed to see if it could be placed safely and record electrical signals. Participants had a follow-up visit 30 days later. The goal was to check for any problems and see if the probe works as intended.

What this could mean

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

Active substance
Soft neural probe (device)
What this could lead to
If successful, this could pave the way for safer brain-computer interfaces and better understanding of brain signals.
What could go wrong
This is a very early, small feasibility study with only 5 participants, so results may not apply broadly. The probe is tested in tissue already scheduled for removal, so long-term safety and function in living brain are unknown.

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

5 people

The number who actually took part.

Started

Mar 2025

Finished

Aug 2025

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 80 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 * Adults 18-80 years of age at the time of providing informed consent * Capable of providing written informed consent to participate * Willing to commit to the study evaluations and visit schedule * Undergoing a planned surgery for brain tissue resection of either a tumor or of a epileptogenic lesion * Adequate hepatic, renal, cardiac, and hematologic function according to the following laboratory test criteria: * Absolute neutrophil count ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine ≤ 1.5 mg/dL * Signs of previous or current ischemic cardiac disease or arrhythmia per electrocardiogram assessment * Females of childbearing potential must have a negative serum pregnancy test and agree to use birth control measures during study treatment and for 3 months after its completion * Must not be pregnant or nursing at study entry * Women/men of reproductive potential must have agreed to use an effective contraceptive method Exclusion Criteria * Substance abuse, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) * Allergy to any study materials * Presence of any powered implantable medical device or any medical device implanted in the brain * Weakened immune system due to presence of poorly controlled chronic diseases such as human immunodeficiency virus (seropositive for HIV 1 or 2), decompensated diabetes, decompensated chronic kidney disease, decompensated liver disease, intake of immunosuppressive medications such as high-dose corticosteroids, or a previous diagnosis of congenital or acquired immunodeficiency * Exposure to any type of chemotherapy in the past 3 months * Radiation therapy in the surgical area within the last year * Delay to the base operation creates additional risk for the patient due to uncontrolled elevated ICP or emergency surgery * Active infection, bleeding, or hematoma * Patients with previous resection surgery in the planned surgical area * Previous stroke in the affected tissue * Currently high levels of inflammation as indicated by ESR, CRP, or PCT blood test * Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, or active systemic infection) that is likely to interfere with study procedures. * Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to the planned neurosurgical intervention. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to the planned neurosurgical intervention are acceptable. * Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. * Any other psychological, family or geographic problem that may make compliance with the study protocol difficult. * Life expectancy of less than 3 months. * Major surgery within 4 weeks prior to planned neurosurgical intervention

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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

  • Centro de Vacunación e Investigación SA (CEVAXIN) - The Panama Clinic

    Panama City, Panama

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