Feasibility of Safe Insertion and Neural Recording With a Soft Neural ProbeFINESSENCT06673264
First-In-human Trial of a NovEl Soft and Stretchable Neural probE
A study testing Soft Neural Probe in people with Feasibility of Safe Insertion and Neural Recording With a Soft Neural Probe and Brain Surgery, run by Axoft, Inc. at 1 site in Panama.
Trial summary
The goal of this interventional study is to find out the feasibility of whether the soft neural probe can be used in human brain tissue. The main questions it aims to answer are: Are there any problems when inserting the soft neural probe into brain tissue? Can the soft neural probe record electrical signals from the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Feasibility of Safe Insertion and Neural Recording With a Soft Neural Probe, Brain Surgery
- What is being tested?
- Soft Neural Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 sitePanama
- Study dates
- 14 Mar 2025to 21 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Panama1 site
Centro de Vacunación e Investigación SA (CEVAXIN) - The Panama Clinic
Panama City
About this study
Official title: FINESSE: First-In-Human Trial Using a NovEl Soft Neural Probe: an IDEAL StagE 1 Study
The goal of this interventional study is to find out the feasibility of whether the soft neural probe can be used in human brain tissue. The main questions it aims to answer are:
- Are there any problems when inserting the soft neural probe into brain tissue?
- Can the soft neural probe record electrical signals from the brain tissue?
Participants will:
- During their already scheduled brain tumor or epileptic tissue removal, have the soft neural probe inserted into the section of brain tissue that is due to be removed
- Visit the clinic for follow up after 30 days for checkups
- Conditions
- Feasibility of Safe Insertion and Neural Recording With a Soft Neural Probe, Brain Surgery
- Being tested
- Soft Neural Probe
- Keywords
- First-in-human, Brain-Computer Interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Neural ProbeDevice
sub-acute insertion of the soft neural probe with neural signal recording
| Study group | Role | What they receive |
|---|---|---|
| Receives soft neural probe device insertion | Experimental | Not described Receives: Device: Soft Neural Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by adverse events
Assessed by enumerating reported adverse events occurring from use of the study device during the study period.
Measured: From surgery to 30-day follow up
Secondary outcomes (3)
Feasibility assessed by use
Assessed by average of Net Promoter Score
Measured: From the introduction of the soft neural probe into the surgery field until 20 minutes later
Local tissue effect biocompatibility via measurement of area of affected tissue
Histopathological evaluation of the resected tissue including the insertion track of the soft neural probe. Area of tissue damaged as defined by H\&E staining
Measured: Histopathology conducted within 3 months following tissue resection
Number of Participants where Neural Signals are Recorded from the Soft Neural Probe
Measured: From the introduction of the soft neural probe into the surgery field until 20 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start14 Mar 2025
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility of Safe Insertion and Neural Recording With a Soft Neural ProbeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants undergoing brain resection due to tumor or epilepsy
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673264
- Sponsor's protocol ID
- PLAN-000045
- Acronym
- FINESSE
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FINESSE: First-In-Human Trial Using a NovEl Soft Neural Probe: an IDEAL StagE 1 Study
- ClinicalTrials.gov ID
- NCT06673264
- Acronym / sponsor ID
- FINESSE / PLAN-000045
- Conditions
- Feasibility of Safe Insertion and Neural Recording With a Soft Neural Probe, Brain Surgery
- Keywords
- First-in-human, Brain-Computer Interface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Axoft, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to find out the feasibility of whether the soft neural probe can be used in human brain tissue. The main questions it aims to answer are:
- Are there any problems when inserting the soft neural probe into brain tissue?
- Can the soft neural probe record electrical signals from the brain tissue?
Participants will:
- During their already scheduled brain tumor or epileptic tissue removal, have the soft neural probe inserted into the section of brain tissue that is due to be removed
- Visit the clinic for follow up after 30 days for checkups
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants undergoing brain resection due to tumor or epilepsy
| Arm | Type | Receives |
|---|---|---|
| Receives soft neural probe device insertion | Experimental | Device: Soft Neural Probe |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft Neural Probesub-acute insertion of the soft neural probe with neural signal recording | Device | Receives soft neural probe device insertion |
Primary outcome
Feasibility assessed by adverse events
Time frame: From surgery to 30-day follow up
Assessed by enumerating reported adverse events occurring from use of the study device during the study period.
3 secondary outcomes
Feasibility assessed by use
Time frame: From the introduction of the soft neural probe into the surgery field until 20 minutes later
Local tissue effect biocompatibility via measurement of area of affected tissue
Time frame: Histopathology conducted within 3 months following tissue resection
Number of Participants where Neural Signals are Recorded from the Soft Neural Probe
Time frame: From the introduction of the soft neural probe into the surgery field until 20 minutes later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Neural Probe in people with Feasibility of Safe Insertion and Neural Recording With a Soft Neural Probe and Brain Surgery, run by Axoft, Inc. at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by adverse events (time frame: From surgery to 30-day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.