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

NCT07465796 | Recruiting DMC

• 2 other identifiers: CL_CNS_00008HREC 474/25
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Tumor; Electrocorticography; Brain

Keywords

Intraoperative Neurophysiology; Cortical Mapping; Cortical Stimulation; Brain-Computer Interface (BCI)

Outcome Measures

Primary Outcomes (1)

• Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device

  Monitoring of all device/procedure-related adverse events including, but not limited to, device-related postoperative observations for persistent seizures or status epilepticus

  From enrollment to the end of postoperative six-week follow-up visit

Secondary Outcomes (4)

• Presence or absence of spontaneous neural activity on recording electrodes

  At enrollment

• Signal-to-noise ratio of recorded signals

  At enrollment

• Evaluate local field potential neural activity before and after stimulation

  At enrollment

• Incidence and characterization of device deficiencies during intraoperative use

  At enrollment

Study Arms (2)

Recording only

EXPERIMENTAL

Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded. No stimulation will be delivered.

Device: Electrocorticography for neural recording

Recording and Stimulation

EXPERIMENTAL

Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded and stimulation will be delivered

Device: Electrocorticography for neural recording and electrical stimulation

Interventions

Electrocorticography for neural recording DEVICE

Electrocorticography probe placed on the brain surface for neural recording

Recording only

Electrocorticography for neural recording and electrical stimulation DEVICE

Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation

Recording and Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant status during craniotomy

Sponsors & Collaborators

• Royal Melbourne Hospital, Australia: collaborator
• Coherence Neuro Australia Pty Limited: lead

Study Sites (1)

The Royal Melbourne Hospital, Department of Neurosurgery 4 East

Melbourne, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Glioma; Neoplasms

Interventions

Electrocorticography; Electric Stimulation

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Physical Stimulation; Investigative Techniques

Central Study Contacts

Andrew Morokoff, MBBS PhD FRACS

CONTACT

+61 393 482 712; morokoff@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 12, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)