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

Sponsor
Coherence Neuro Australia Pty Limited
Study ID
NCT07465796
Status
Recruiting
Apply to this trial

Conditions

  • Brain
  • Electrocorticography
  • Glioma
  • Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Mar 12, 2026
Start date
May 22, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • 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

Primary Outcome Measure

Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device [ Time Frame: From enrollment to the end of postoperative six-week follow-up visit ]

Central Contacts

Find similar trials

Nationwide
Brain cancer trialsOncology trialsNeuro-oncology trials

Related Studies