Clinical trials: Intracranial Pressure Increase
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
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 Edema, TBI (Traumatic Brain Injury)
Dynamic Decompressive Craniotomy
Prospective observational study on patients undergoing decompressive craniotomy
- Conditions
- Brain Edema, TBI (Traumatic Brain Injury), Stroke, Acute, Cerebral Hemorrhage
- Trial name
- NCT05051488
- Testing
- Dynamic craniotomy
- Volunteers
- 20 people
- Sponsor
- Rohit Khanna, MD
Intracranial Pressure Increase
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external…
- Trial name
- NCT03418753
- Testing
- EyeBOX for ICP
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Oculogica, Inc.
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
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
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
Idiopathic Intracranial Hypertension
Venous Sinus Stenting With the River Stent in IIH
The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH).
- Trial name
- NCT03556085
- Testing
- Venous sinus stenting (Serenity River)
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- Serenity Medical, Inc.
Idiopathic Intracranial Hypertension
A Trial to Determine the Efficacy and Safety of Presendin in IIH
Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches.
- Trial name
- IIH EVOLVE (NCT05347147)
- Testing
- Presendin
- Where
- 24 sites in United States, Australia and 4 more
- Volunteers
- 14 people
- Sponsor
- Invex Therapeutics Ltd.
Traumatic Brain Injury, Intracranial Hypertension
A Non-invasive Intracranial Pressure (nICP) Monitoring System
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe.
- Trial name
- NCT05632302
- Testing
- nICP
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Crainio Ltda
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, 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
Hydrocephalus, Hydrocephalus in Children
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
- Conditions
- Hydrocephalus, Hydrocephalus in Children, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- Trial name
- NCT05397106
- Testing
- CODMAN CERTAS Plus Programmable Valve
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 160 people
- Sponsor
- Integra LifeSciences Corporation
Central Nervous System Infections, Pseudotumor Cerebri
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
- Conditions
- Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer
- Trial name
- NCT04796935
- Testing
- Tactile Imaging (VerTouch), Control (palpation)
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- IntuiTap Medical, Inc
Idiopathic Intracranial Hypertension (IIH)
Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
The objective of this clinical investigation is to evaluate and demonstrate the clinical benefit, performance, and safety of the SILANCE Stent, which is specifically designed for the treatment of patients with symptomatic sinus…
- Trial name
- SONIC (NCT07561268)
- Testing
- SILANCE Stent Implantation
- Volunteers
- 99 people
- Sponsor
- Acandis GmbH
Hydrocephalus, NPH (Normal Pressure Hydrocephalus)
CERTAS Programmable Valve Registry
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
- Conditions
- Hydrocephalus, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- Trial name
- CERTAS (NCT04207229)
- Testing
- CODMAN CERTAS Programmable Valves
- Where
- 8 sites in Germany, Netherlands
- Volunteers
- 35 people
- Sponsor
- Integra LifeSciences Corporation