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Active, not recruitingNCT03249220CBMS FIHUpdated Nov 28, 2025

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

An interventional study of Placement of the CBMS Probe in Brain Injuries, sponsored by Carag AG. Active, not recruiting at 2 sites in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Carag AG · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Brain Injuries

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03

In context

Brain Injuries

2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 1 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Carag AG is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    CBMS

    Device: Placement of the CBMS Probe

Interventions

  • DevicePlacement 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.

06

What researchers measure

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.

    Time frame: Up to 28 days until probe removal

Secondary outcomes

  1. 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.

    Time frame: Until 7 days after probe removal

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Study locations

2 sites
  • Inselspital Bern
    Bern, Canton of Bern 3010, Switzerland
  • Centre Hospitalier Universitaire Vaudois CHUV
    Lausanne, Canton of Vaud 1011, Switzerland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03249220
Lead sponsor
Carag AG
Responsible party
Sponsor
First posted
Aug 15, 2017
Start date
Sep 1, 2020
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Nov 28, 2025

Study contacts

Werner Z'Graggen
principal investigator · Insel Gruppe AG, University Hospital Bern

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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