NCT07465796 A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
| NCT ID | NCT07465796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Coherence Neuro Australia Pty Limited |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-05-22 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07465796 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07465796 currently recruiting?
Yes, NCT07465796 is actively recruiting participants. Contact the research team at morokoff@unimelb.edu.au for enrollment information.
Where is the NCT07465796 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT07465796 clinical trial?
NCT07465796 is sponsored by Coherence Neuro Australia Pty Limited. The trial plans to enroll 10 participants.