Brain InjuriesCBMS FIHNCT03249220
Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients
A study testing Placement of the CBMS Probe in people with Brain Injuries, run by Carag AG at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Placement of the CBMS Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Sep 2020to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Inselspital Bern
Bern, Canton of Bern, 3010
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official 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
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
- Being tested
- Placement of the CBMS Probe
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of the CBMS ProbeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CBMS | Experimental | Not described Receives: Device: Placement of the CBMS Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Until 7 days after probe removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carag AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Werner Z'Graggen, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249220
- Sponsor's protocol ID
- 2015.5703
- Acronym
- CBMS FIH
- Status last verified
- Nov 2025
- First submitted
- 2 Aug 2017
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03249220
- Acronym / sponsor ID
- CBMS FIH / 2015.5703
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Carag AGIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBMS | Experimental | Device: Placement of the CBMS Probe |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of the CBMS ProbePatients 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. | Device | CBMS |
Primary outcome
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.
1 secondary outcome
Safety related to catheter insertion and monitoring
Time frame: Until 7 days after probe removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Injuries
Not yet recruiting
Exercise and Physical Activity in Adults With Acquired Brain Injury
Acquired Brain Injury
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Exercise and Physical Activity in Children With Pediatric Acquired Brain Injury
Acquired Brain Injury
Active, not recruitingObservational study
Adverse Events During Physical Therapy in Neurocritical ICU Patients
Critical Illness, Brain Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Z'Graggen principal investigator
Insel Gruppe AG, University Hospital Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of the CBMS Probe in people with Brain Injuries, run by Carag AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD (time frame: Up to 28 days until probe removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.