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

NCT06673264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-09-18

No results posted yet for this study

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

Conditions

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

Interventions

DEVICE

Soft Neural Probe

sub-acute insertion of the soft neural probe with neural signal recording

Sponsors & Collaborators

  • Axoft, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2025-08-21
Completion
2025-08-21
FDA Device
Yes

Countries

  • Panama

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06673264 on ClinicalTrials.gov