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

NCT03249220 | Active Not Recruiting

• 1 other identifier: 2015.5703
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety related to catheter insertion and monitoring

  Until 7 days after probe removal

Study Arms (1)

CBMS

EXPERIMENTAL

Device: Placement of the CBMS Probe

Interventions

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.

CBMS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Carag AG: lead

Study Sites (2)

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Werner Z'Graggen

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 15, 2017
• Study Start: September 1, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CH (2)