A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
Recruiting
N/A
Interventional Study
Glioma
Tumor
Electrocorticography
Brain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 10 (estimated)
- Sponsor
- Coherence Neuro Australia Pty Limited · Industry
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About This Trial
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 wi…
Trial Locations
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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 Coo…
Contacts