New brain monitor tested on one patient
NCT ID NCT03249220
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device that measures blood flow, pressure, and temperature inside the brain, while also draining fluid. It was designed for patients with serious brain injuries who already need standard monitoring. Only one person took part, and the goal was to see if the device works safely and gives accurate readings.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1 person
The number who actually took part.
- Started
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Sep 2020
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Canton of Vaud, 1011, Switzerland
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Inselspital Bern
Bern, Canton of Bern, 3010, Switzerland
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