About this trial
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.
Eligibility criteria
Qualifiers
Newly diagnosed supratentorial glioma requiring resection
Glioma mass reaches or close to cortical surface
Adults aged 18-75
Planned for open craniotomy under Total Intravenous Anesthesia (TIVA)
Disqualifiers
Prior craniotomy at the same anatomical location
Plan for awake craniotomy
Any history of seizures prior to craniotomy
Any history of coagulopathy or coagulation disorders
Trial design
Treatments tested in this trial
- Electrocorticography for neural recording
- Electrocorticography for neural recording and electrical stimulation
Treatment groups
Sponsors and collaborators
Coherence Neuro Australia Pty Limited
Lead sponsor
Royal Melbourne Hospital, Australia
Collaborator