Health TrialsbyHealthPanel

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

ConditionsGliomaTumorElectrocorticographyBrain
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Electrocorticography for neural recording

    Device

    Electrocorticography probe placed on the brain surface for neural recording

  • Electrocorticography for neural recording and electrical stimulation

    Device

    Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Recording onlyExperimental treatment 1 intervention
Group B: Recording and StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device

Monitoring of all device/procedure-related adverse events including, but not limited to, device-related postoperative observations for persistent seizures or status epilepticus

Time frame
From enrollment to the end of postoperative six-week follow-up visit

Secondary outcomes

1

Presence or absence of spontaneous neural activity on recording electrodes

Presence or absence of spontaneous cortical signals on each electrode within the array

Time frame
At enrollment
2

Signal-to-noise ratio of recorded signals

Signal-to-noise ratio of recorded signals on each recording electrode

Time frame
At enrollment
3

Evaluate local field potential neural activity before and after stimulation

Preliminary comparison of neural power spectra of local field potentials before and after stimulation

Time frame
At enrollment
4

Incidence and characterization of device deficiencies during intraoperative use

Evaluation of the operating surgeon's responses to a study specific questionnaire including free text description of deficiency, categorization of the type of deficiency as well as outcomes and potential outcomes of deficiencies.

Time frame
At enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coherence Neuro Australia Pty Limited

Lead sponsor

Royal Melbourne Hospital, Australia

Collaborator

Source ClinicalTrials.gov
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