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

June 1, 2026 updated by: Coherence Neuro Australia Pty Limited

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Brain tumor resection surgery involves a balance between removing tumor and preserving healthy tissue. Current standard-of-care mapping tools use limited electrode configurations on rigid substrates to stimulate and record brain activity for identifying functional brain areas to avoid. A more flexible and high electrode-count tool to map the tumor characteristics based on spontaneous neural activity could strengthen surgical outcomes.

Emerging evidence also demonstrates that brain tumors, such as gliomas, are not biologically isolated but instead integrate functionally into neural circuits. Electrical stimulation-based strategies could provide novel treatment modalities that target the neural-tumour interactions and improve patient outcomes.

This clinical investigation is a First-in-Human exploratory study of the CIPHER System, including a novel highly flexible, electrode-dense thin-film cortical probe developed for neurophysiological mapping and stimulation during brain tumour resection surgery. The study is designed to evaluate the safety, basic performance, and handling characteristics of the CIPHER System during short-duration intraoperative use.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital, Department of Neurosurgery 4 East
        • Contact:
        • Principal Investigator:
          • Andrew Morokoff, MBBS PhD FRACS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Electrocorticography for neural recording
Electrocorticography probe placed on the brain surface for neural recording
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
Device: Electrocorticography for neural recording and electrical stimulation
Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of spontaneous neural activity on recording electrodes
Time Frame: At enrollment
Presence or absence of spontaneous cortical signals on each electrode within the array
At enrollment
Signal-to-noise ratio of recorded signals
Time Frame: At enrollment
Signal-to-noise ratio of recorded signals on each recording electrode
At enrollment
Evaluate local field potential neural activity before and after stimulation
Time Frame: At enrollment
Preliminary comparison of neural power spectra of local field potentials before and after stimulation
At enrollment
Incidence and characterization of device deficiencies during intraoperative use
Time Frame: At enrollment
Evaluation of the operating surgeon's responses to a study specific questionnaire including free text description of deficiency, categorization of the type of deficiency as well as outcomes and potential outcomes of deficiencies.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coherence Neuro Australia Pty Limited

Collaborators

Royal Melbourne Hospital, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL_CNS_00008
  • HREC 474/25 (Other Identifier: St Vincent's Hospital Melbourne)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared in order to preserve patient confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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