A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device
研究概览
简要总结
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.
详细描述
Brain tumor resection surgery involves a balance between removing tumor and preserving healthy tissue. Current standard-of-care mapping tools use limited electrode configurations on rigid substrates to stimulate and record brain activity for identifying functional brain areas to avoid. A more flexible and high electrode-count tool to map the tumor characteristics based on spontaneous neural activity could strengthen surgical outcomes.
Emerging evidence also demonstrates that brain tumors, such as gliomas, are not biologically isolated but instead integrate functionally into neural circuits. Electrical stimulation-based strategies could provide novel treatment modalities that target the neural-tumour interactions and improve patient outcomes.
This clinical investigation is a First-in-Human exploratory study of the CIPHER System, including a novel highly flexible, electrode-dense thin-film cortical probe developed for neurophysiological mapping and stimulation during brain tumour resection surgery. The study is designed to evaluate the safety, basic performance, and handling characteristics of the CIPHER System during short-duration intraoperative use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Recording only
Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded. No stimulation will be delivered.
干预措施: Electrocorticography for neural recording (Device)
Recording and Stimulation
Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded and stimulation will be delivered
干预措施: Electrocorticography for neural recording and electrical stimulation (Device)
结局指标
主要结局
Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device
时间窗: From enrollment to the end of postoperative six-week follow-up visit
Monitoring of all device/procedure-related adverse events including, but not limited to, device-related postoperative observations for persistent seizures or status epilepticus
次要结局
- Presence or absence of spontaneous neural activity on recording electrodes(At enrollment)
- Signal-to-noise ratio of recorded signals(At enrollment)
- Evaluate local field potential neural activity before and after stimulation(At enrollment)
- Incidence and characterization of device deficiencies during intraoperative use(At enrollment)