Clinical trials: ICP Monitoring
Stroke
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care
The HS-1000 device, an investigational intracranial monitoring device, has the potential to safely and quickly diagnose and assess stroke (and potentially other neurologic conditions) with minimal discomfort to patients.
- Trial name
- NCT02772484
- Testing
- HS-1000
- Where
- Armenia
- Volunteers
- 24 people
- Sponsor
- HeadSense Medical
Intracranial Hypertension
Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
In current practice patients with a suspected increase of intracranial pressure (ICP) will undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a marker for ICP).
- Trial name
- NCT02773901
- Testing
- HS-1000
- Where
- 3 sites in Denmark, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- HeadSense Medical
Intracranial Hypertension, Abnormality of Intracranial Pressure
Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device
For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in…
- Trial name
- NCT03865576
- Testing
- Non-invasive ICP measurement
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Boston Neurosciences
Brain Injuries
Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device 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…
- Trial name
- CBMS FIH (NCT03249220)
- Testing
- Placement of the CBMS Probe
- Where
- 2 sites in Switzerland
- Volunteers
- 1 people
- Sponsor
- Carag AG
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants…
- Conditions
- Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Trial name
- BrainProtect (NCT07872982)
- Testing
- BrainProtect System, Standard perioperative management
- Where
- 4 sites in United States, Austria and 2 more
- Volunteers
- 304 people
- Sponsor
- Scienceforbrain, UAB
Traumatic Brain Injury
Crainio Non-invasive ICP Monitor for TBI
The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring.
- Trial name
- NCT06453733
- Testing
- Crainio
- Where
- United Kingdom
- Volunteers
- 54 people
- Sponsor
- Crainio Ltda
Intracranial Hypertension, Brain Injuries
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.
- Conditions
- Intracranial Hypertension, Brain Injuries, Stroke, Hydrocephalus
- Trial name
- NCT02773888
- Testing
- HS-1000
- Where
- 5 sites in Japan
- Volunteers
- 80 people
- Sponsor
- HeadSense Medical
Intracranial Hypertension
Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external…
- Trial name
- NCT02695264
- Testing
- HS-1000 recording
- Where
- United States
- Sponsor
- HeadSense Medical
Brain Injuries, Intracranial Hypertension
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical…
- Trial name
- NCT02772471
- Testing
- HS-1000
- Where
- Norway
- Volunteers
- 40 people
- Sponsor
- HeadSense Medical
Presence of High Intracranial Pressure
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.
- Trial name
- NCT02284217
- Testing
- EVD
- Where
- 7 sites in United States, Germany
- Volunteers
- 100 people
- Sponsor
- HeadSense Medical
Brain Injuries, Intracranial Hypertension
Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured.
- Trial name
- NCT02773862
- Testing
- HS-1000
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- HeadSense Medical