Trials / Completed
CompletedNCT06673264
First-In-human Trial of a NovEl Soft and Stretchable Neural probE
FINESSE: First-In-Human Trial Using a NovEl Soft Neural Probe: an IDEAL StagE 1 Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Axoft, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Soft Neural Probe | sub-acute insertion of the soft neural probe with neural signal recording |
Timeline
- Start date
- 2025-03-14
- Primary completion
- 2025-08-21
- Completion
- 2025-08-21
- First posted
- 2024-11-04
- Last updated
- 2025-09-18
Locations
1 site across 1 country: Panama
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06673264. Inclusion in this directory is not an endorsement.