Actively Recruiting
A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
Led by Coherence Neuro Australia Pty Limited · Updated on 2026-06-03
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Coherence Neuro Australia Pty Limited
Lead Sponsor
R
Royal Melbourne Hospital, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the CIPHER System in patients undergoing brain tumor removal surgery for newly diagnosed supratentorial glioma. This First-in-Human clinical investigation aims to assess the safety and basic performance of a novel, highly flexible, electrode-dense cortical probe designed for neurophysiological mapping and stimulation during brain tumor resection. The study focuses on how well the device functions and its handling characteristics during short-term use in surgery. Participants will have the CIPHER Probe placed on the surface of the brain during standard tumor removal surgery. Two groups are studied: one where only neural activity is recorded and another where both recording and electrical stimulation are performed using the probe. No stimulation is delivered in the recording-only group. The device is tested on the main tumor area and the surrounding tissue margin just before tumor removal. During the study, participants will be monitored through hospital visits during their recovery period, including follow-ups at two and six weeks after surgery. Researchers will collect data on any device or procedure-related adverse events, spontaneous neural activity, signal quality, and device deficiencies. The total study period includes enrollment through the six-week postoperative follow-up to evaluate safety and device performance.
CONDITIONS
Brief Title
A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed supratentorial glioma requiring resection
- Glioma mass reaches or is close to cortical surface
- Adults aged 18 to 75 years
- 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 will not qualify if you...
- Prior craniotomy at the same anatomical location
- Planned awake craniotomy
- Any history of seizures prior to craniotomy
- Any history of coagulopathy or coagulation disorders
- Pregnancy during craniotomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants undergo brain tumor resection surgery during which the CIPHER System probe is placed on the brain surface to record neural activity, with or without electrical stimulation, to evaluate device safety and performance.
1 surgical procedure visit and hospital stay
Duration - 6 weeks
Participants are monitored for device and procedure-related adverse events and recovery over six weeks following surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
The Royal Melbourne Hospital, Department of Neurosurgery 4 East
Melbourne, Victoria, Australia, 3050
Actively Recruiting
Research Team
A
Andrew Morokoff, MBBS PhD FRACS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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