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

NCT07465796 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-18

No results posted yet for this study

Summary

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

Interventions

DEVICE

Electrocorticography for neural recording

Electrocorticography probe placed on the brain surface for neural recording

DEVICE

Electrocorticography for neural recording and electrical stimulation

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

Sponsors & Collaborators

  • Royal Melbourne Hospital, Australia

    collaborator UNKNOWN

  • Coherence Neuro Australia Pty Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07465796 on ClinicalTrials.gov