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New brain monitor tested on one patient

NCT ID NCT03249220

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

1 person

The number who actually took part.

Started

Sep 2020

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Centre Hospitalier Universitaire Vaudois CHUV

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Inselspital Bern

    Bern, Canton of Bern, 3010, Switzerland

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