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Die klinische Studie NCT07465796 (CIPHER) für Gliom, Tumor, Electrocorticography, Gehirn ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma 10 First-in-Human

Noch nicht rekrutierend
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Die klinische Studie NCT07465796 (CIPHER) ist eine interventionsstudie zur Untersuchung von Gliom, Tumor, Electrocorticography, Gehirn und hat den Status noch nicht rekrutierend. Der Start ist für 1. März 2026 geplant, bis 10 Teilnehmer aufgenommen werden. Durchgeführt von Coherence Neuro Australia Pty Limited wird der Abschluss für 1. September 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 12. März 2026 aktualisiert.
Kurzbeschreibung

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-...
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Ausführliche Beschreibung
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 ...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
GliomTumorElectrocorticographyGehirn
Weitere Studien-IDs
  • CIPHER
  • CL_CNS_00008
  • HREC 474/25 (Andere Kennung) (St Vincent's Hospital Melbourne)
NCT-Nummer
NCT07465796
Studienbeginn (tatsächlich)
2026-03
Zuletzt aktualisiert
2026-03-12
Studienende (vorauss.)
2026-09
Geplante Rekrutierung
10
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
Intraoperative Neurophysiology
Cortical Mapping
Cortical Stimulation
Brain-Computer Interface (BCI)
Primäres Ziel
Machbarkeitsprüfung für Medizinprodukte
Zuteilungsmethode
Nicht randomisiert
Interventionsmodell
Sequentiell
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellRecording only
Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded. No stimulation will be delivered.
Electrocorticography for neural recording
Electrocorticography probe placed on the brain surface for neural recording
ExperimentellRecording and Stimulation
Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded and stimulation will be delivered
Electrocorticography for neural recording and electrical stimulation
Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
From enrollment to the end of postoperative six-week follow-up visit
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Presence or absence of spontaneous neural activity on recording electrodes
Presence or absence of spontaneous cortical signals on each electrode within the array
At enrollment
Signal-to-noise ratio of recorded signals
Signal-to-noise ratio of recorded signals on each recording electrode
At enrollment
Evaluate local field potential neural activity before and after stimulation
Preliminary comparison of neural power spectra of local field potentials before and after stimulation
At enrollment
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.
At enrollment
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • 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

  • 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
Coherence Neuro Australia Pty Limited logoCoherence Neuro Australia Pty Limited
Royal Melbourne Hospital, Australia logoRoyal Melbourne Hospital, Australia
Zentrale Studienkontakte
Kontakt: Andrew Morokoff, MBBS PhD FRACS, +61 393 482 712, [email protected]
1 Studienstandorte in 1 Ländern

Victoria

The Royal Melbourne Hospital, Department of Neurosurgery 4 East, Melbourne, Victoria, 3050, Australia
Andrew Morokoff, MBBS PhD FRACS, Kontakt, +61 393 482 712, [email protected]
Andrew Morokoff, MBBS PhD FRACS, Hauptprüfer