A Study to Evaluate the SENSE Device's Ability to Detect TBI
Recruiting
Observational Study
Traumatic Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 150 (estimated)
- Sponsor
- Sense Diagnostics, LLC · Industry
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About This Trial
The study population will consist of 3 mutually-exclusive sets of patients and subjects:
* TBI patients with intracranial bleeding
* TBI patients without intracranial bleeding
* Control subjects with normal brain health.
Research subjects ages 22 and older will be enrolled. All TBI patients must be monitored with the SENSE Device within 6 hours of a diagnostic head CT scan ordered by a treating …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* • Male or female adults age 22 and older
* Patients with TBI who have a head CT scan obtained in the mobile stroke unit, emergency department, or hospital, ordered by a treating clinician OR control subjects with normal brain health.
* For patients with traumatic intracra…
Contacts