A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma (NCT07465796) | Clinical Trial Compass
RecruitingNot Applicable
A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
Australia10 participantsStarted 2026-05-22
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device
Timeframe: From enrollment to the end of postoperative six-week follow-up visit