Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device 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.

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital Bern, Bern, Canton of Bern, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placement of the CBMS Probe

Device

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.

Primary outcomes

Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD

Time frame: Up to 28 days until probe removal

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.

Secondary outcomes

Safety related to catheter insertion and monitoring

Time frame: Until 7 days after probe removal

Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices.

Sponsors and collaborators

Lead sponsor

Carag AG

Industry

Registry information

Official study title

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

Acronym: CBMS FIH

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Aug 15, 2017
Registry last updated: Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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