A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

Completed

Phase N/A Results N/A

Trial Description

To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.

Conditions

Interventions

  • Installation of the neuromonitoring system (NeMo System including NeMo Patch and NeMo Probe) Device
    Intervention Desc: A plaster based patch (NeMo Patch) and a combined probe for ICP monitoring and near infrared spectroscopy (NIRS) are applied as sensors. Data are collected by a NIRS instrument (NeMo Control Unit)
    ARM 1: Kind: Experimental
    Label: TBI and SAH patients, one arm
  • NeMo Patch and NeMo Probe Device
    Intervention Desc: A plaster based patch (NeMo Patch) and a combined probe for ICP monitoring and near infrared spectroscopy (NIRS) are applied as sensors. Data are collected by a NIRS instrument (NeMo Control Unit)
    ARM 1: Kind: Experimental
    Label: NeMo Patch and NeMo Probe
    Description: TBI and SAH patients, one arm

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values. Day 28 after removal of medical device Yes
Secondary To demonstrate the ability of the neuromonitoring system to detect secondary ischemic events in patients with severe subarachnoid haemorrhage (SAH) or severe traumatic brain injury (TBI). Day 28 after removal of medical device No

Sponsors