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

Not Applicable

• Conditions: Feasibility of Safe Insertion and Neural Recording With a Soft Neural Probe; Brain Surgery

• Registration Number: NCT06673264
• Lead Sponsor: Axoft, Inc.

Brief 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 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2025-03-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility assessed by adverse events	From surgery to 30-day follow up	Assessed by enumerating reported adverse events occurring from use of the study device during the study period.

Secondary Outcome Measures

Name	Time	Method
Local tissue effect biocompatibility via measurement of area of affected tissue	Histopathology conducted within 3 months following tissue resection	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
Feasibility assessed by use	From the introduction of the soft neural probe into the surgery field until 20 minutes later	Assessed by average of Net Promoter Score
Number of Participants where Neural Signals are Recorded from the Soft Neural Probe	From the introduction of the soft neural probe into the surgery field until 20 minutes later

Trial Locations

Locations (1)

Centro de Vacunación e Investigación SA (CEVAXIN) - The Panama Clinic; 🇵🇦 Panama City, Panama