Clinical trial · Interventional
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
NCT02773888CI-TRIAL-00026180suspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment temporarily held for site retraining
Summary
Brief summary (as posted)
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. HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injuries | — | UNRESOLVED | — |
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Hydrocephalus | — | UNRESOLVED | — |
| Intracranial Hypertension | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-1000 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HS-1000 recording
- description
- ICP readings will be recorded in parallel from both the invasive ICP monitor, and HeadSense's non-invasive ICP monitor. Each recording session will be done until an aggregate of at least 30 minutes worth of quality data is collected, depending on the patient's clinical condition. For each patient, two recording sessions will be completed for 30-60 minutes each for 120 minutes total.
- interventionNames
- Device: HS-1000
Primary outcomes (1)
- measure
- Number of ICP values obtained by the HS device that correlate to ICP using current standards
- timeFrame
- 30 minutes
Secondary outcomes (1)
- measure
- Incidence of adverse events during and after recording sessions
- timeFrame
- 96 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subjects, aged 14 years old and over at screening visit * Patient with invasive ICP monitor due to suspected ICP elevation, regardless of etiology * Survival expectancy greater than 48 hours * Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol * Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study Exclusion Criteria: * Subject with ear disease, ear trauma * Subject with a punctured or discontinuous dura layer (must be intact) * Subject with cerebral fluid (CSF) leakage * Known allergy or hypersensitivity to any of the test materials or contraindication to test materials * Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s) * Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g. mental condition)
References
Publications (0)
Data not yet available
No reference posted for this study.