Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients (CBMS FIH)

Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device That Allows the Measurement of Regional Cerebral Blood Flow (rCBF), Intracranial Pressure (ICP), Brain Temperature Monitoring and Ventricular Cerebrospinal Fluid (CSF) Drainage in Brain-injured Patients

Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Brain Injuries
• Intervention / Treatment: Device: Placement of the CBMS Probe

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Bern
    • Bern, Canton of Bern, Switzerland, 3010
      • Inselspital Bern
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult male or female patient, aged 18 - 75 years
• Brain injured patients with acute intracranial hemorrhage (including aneurysmal subarachnoid hemorrhage (SAH) and spontaneous intracerebral hemorrhage (ICH)) who are admitted to the ICU and have an indication for ICP monitoring and CSF drainage, as per standard patient care
• Informed consent obtained for research in emergency situations according to HRA art. 30 & 31 at time of inclusion

Exclusion Criteria:

• Known kidney disease, defined as plasma creatinine > 120 μmol/l
• Known liver disease, defined as AST > 200 IU/L
• Over-active thyroid or benign tumors of the thyroid
• History of allergic disorders, including allergic reactions, against contrast agents containing iodine, or against ICG
• Patients which have received one of the following medications before being admitted to ICU: Haloperidol, Meperidine, Methadone, Morphine, Phenobarbital and Rifamycin.
• Patients with wounds or scars including the front orbital region.
• Cerebrospinal fluid infection or signs of meningo-encephalitis
• Anemia (hemoglobin < 10 g/dl) or Thalassemia
• Carbon monoxide poisoning
• Acquired pathological or congenital disorders of the cerebral system, being clinically significant, respectively interfering in the investigator's opinion with the conduct of study
• Documented history of bleeding, clotting or coagulation disorders
• Patients who are not suitable for a CT perfusion
• Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical investigation or will not comply with requirements of the study
• Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation
• Pre-existing disability and/or legal representative
• Patients who are kept lawfully in an institution
• Participation in another interventional clinical investigation within the last 30 days before start of treatment
• History of, respectively diagnosis of pregnancy, or breastfeeding patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CBMS

Device: Placement of the CBMS Probe; Patients will be treated according to standard care in place at the investigation site, when intra-ventricular drainage is needed. Patients will receive the new multifunctional device (CBMS Probe) instead of the single function device generally used. Drainage will be performed by routine standards. Temperature, intracranial pressure and cerebral blood flow will be recorded. Treatment decision will be made by the neurointensive care specialist based on standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD	Regional CBF values calculated with the investigational devices (CBMS) are within ranges described in literature, and dynamic changes of regional CBF are consistent to those values obtained with established methods CT perfusion and TCD.	Up to 28 days until probe removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety related to catheter insertion and monitoring	Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices.	Until 7 days after probe removal

Collaborators and Investigators

• Sponsor: Carag AG
• Investigators: Principal Investigator: Werner Z'Graggen, Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Estimated): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 2015.5703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No