Brain surgery gets a High-Tech helper: first human test of CIPHER system begins
NCT ID NCT07465796
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new device called the CIPHER System, which records brain activity during surgery to remove a type of brain tumor called glioma. Ten adults with newly diagnosed glioma will have the device placed on their brain surface during standard tumor removal. The main goals are to check if the device is safe and if it can record brain signals properly. This is a data-gathering study, not a treatment trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CIPHER System (electrocorticography probe)
- What this could lead to
- If successful, this could lead to better tools for surgeons to identify tumor boundaries during brain surgery.
- What could go wrong
- This is a very early, small study (10 people) focused on safety and data collection, not treatment. The device may not improve outcomes or could cause side effects like seizures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Royal Melbourne Hospital, Department of Neurosurgery 4 East
RECRUITINGMelbourne, Victoria, 3050, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental therapy aims to turn brain tumors against themselves
- Radiation probe targets Hard-to-Treat tumors
- Radioactive tiles target brain tumors in frail patients
- Breathing CO2 during brain scans could reveal hidden tumor disruption
- AI reads tumor slides to match cancer patients with trials
- Brain scan may replace biopsy for tumor grading