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NCT05155800 · ClinicalTrials.gov registry record
A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury
A clinical trial, sponsored by Sense Diagnostics.
- Completed
- Registry status
- 75
- Enrollment target
NCT05155800: Completed study, sponsored by Sense Diagnostics.
NCT05155800 is a clinical trial that has completed, run by Sense Diagnostics. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05155800 has completed, sponsored by Sense Diagnostics.
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
Study Summary
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 between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.
Primary Outcome
1\. Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls.
Interventions
- DEVICE SDx3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2021-12-28 |
| Est. Completion | 2023-11-15 |
What the finished NCT05155800 record still lists
NCT05155800 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which SDx3 is the first listed.
NCT05155800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05155800 about?
NCT05155800 is a clinical study titled "A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury". 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 between the ages of 22 to 50 will be enrolled. All TBI pati...
What is the current status of trial NCT05155800?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2021-12-28. Estimated completion is 2023-11-15.
What interventions are being tested in trial NCT05155800?
The interventions under investigation include: SDx3 (DEVICE).
Who is sponsoring clinical trial NCT05155800?
This trial is sponsored by Sense Diagnostics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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