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A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
Sponsor: Coherence Neuro Australia Pty Limited
Summary
The goal of this clinical trial is to collect data on the use of the CIPHER System when used by a surgeon during brain tumor removal. The main questions it aims to answer are: * To evaluate the safety of the CIPHER System when used during brain tumor surgery (Primary) * To evaluate the function of the electrodes under recording and stimulating conditions during surgery (Secondary) Participants will undergo standard-of-care surgery to remove their tumor. Just before the tumor is removed, the CIPHER System will be tested on the main tumor and the surrounding margin areas. Participants will be monitored during standard hospital visits occurring during the recovery period after surgery as well as two- and six-weeks after surgery.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-03
Completion Date
2026-09
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Electrocorticography for neural recording
Electrocorticography probe placed on the brain surface for neural recording
Electrocorticography for neural recording and electrical stimulation
Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation
Locations (1)
The Royal Melbourne Hospital, Department of Neurosurgery 4 East
Melbourne, Victoria, Australia