Clinical trial · Interventional
An Evaluation of a Non-invasive Brain Monitor
An Open-Label, Non-Randomized, Comparative Study Designed to Evaluate the Accuracy and Safety of HS-1000 Device, a Non-Invasive Brain Monitor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable of detecting and monitoring various neuropathologies, using the acoustic raw data derived from the noninvasive procedure.
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 | — |
| Subarachnoid Hemorrhage | — | UNRESOLVED | — |
| Vasospasm, Intracranial | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-1000 recording | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HS-1000 recording
- description
- Non-invasive measurements duration with HS-1000 device will be for at least 30 minutes and up to 1 hour of aggregate recording either continuously in the event the patient's clinical condition allows it or in separate recording iterations in the event patient's condition will not allow continuous recording. For each patient, there may be several monitoring intervals from three times a day and up to as long as the patient undergoes brain monitoring, per the discretion of the investigator, patient and/or family members.
- interventionNames
- Device: HS-1000 recording
Primary outcomes (1)
- measure
- Number of recordings that correlate to neuropathology
- timeFrame
- up to 1 hour
- description
- Demonstrate the HS-1000 performance and accuracy in brain monitoring
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult men and women subjects, aged 18 years old and over at screening visit 2. Subjects with neuropathology that the principal investigator considers including in this study. 3. Survival expectancy greater than 72 hours 4. Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol 5. Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study Exclusion Criteria: 1. Local ear infection 2. Known allergy or hypersensitivity to any of the test materials or contraindication to test materials 3. For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding 4. Subarachnoid hemorrhage (SAH), Fisher Grade 4 5. 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) 6. 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)
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