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A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

• Patient able to provide informed consent

• Performance status: Eastern Cooperative Oncology Group (ECOG) scale 0-2

Locations
Other Locations
Australia
The Royal Melbourne Hospital, Department of Neurosurgery 4 East
RECRUITING
Melbourne
Contact Information
Primary
Andrew Morokoff, MBBS PhD FRACS
morokoff@unimelb.edu.au
+61 393 482 712
Time Frame
Start Date: 2026-05-22
Estimated Completion Date: 2026-09
Participants
Target number of participants: 10
Treatments
Experimental: Recording only
Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded. No stimulation will be delivered.
Experimental: Recording and Stimulation
Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded and stimulation will be delivered
Related Therapeutic Areas
Sponsors
Leads: Coherence Neuro Australia Pty Limited
Collaborators: Royal Melbourne Hospital, Australia

This content was sourced from clinicaltrials.gov