First-In-human Trial of a NovEl Soft and Stretchable Neural probE

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