Clinical trial · Interventional
A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrocorticography for neural recording | Device | — | UNRESOLVED |
| Electrocorticography for neural recording and electrical stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Recording only
- description
- Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded. No stimulation will be delivered.
- interventionNames
- Device: Electrocorticography for neural recording
- type
- EXPERIMENTAL
- label
- Recording and Stimulation
- description
- Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded and stimulation will be delivered
- interventionNames
- Device: Electrocorticography for neural recording and electrical stimulation
Primary outcomes (1)
- measure
- Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available