A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCoherence Neuro Australia Pty Limited

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 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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Electrocorticography for neural recording
  • Electrocorticography for neural recording and electrical stimulation

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Coherence Neuro Australia Pty Limited

Lead sponsor

Royal Melbourne Hospital, Australia

Collaborator