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NCT06828107 · ClinicalTrials.gov registry record
A Study to Evaluate the SENSE Device's Ability to Detect TBI
A clinical trial of Traumatic Brain Injury, sponsored by Sense Diagnostics.
- Recruiting
- Registry status
- 150
- Enrollment target
- 6
- Study locations
NCT06828107: Recruiting study of Traumatic Brain Injury, sponsored by Sense Diagnostics.
NCT06828107 is a study of Traumatic Brain Injury that is actively recruiting participants, run by Sense Diagnostics. The registered enrollment target is 150 participants, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (46% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06828107, a study of Traumatic Brain Injury, is actively recruiting participants, sponsored by Sense Diagnostics.
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 6
- Study locations
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 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 clinician and within 24 hours of injury.
Primary Outcome
The SENSE output for each patient will be classified as showing intracranial hemorrhage or no intracranial hemorrhage for each study CT with corresponding SENSE data. The SENSE output will be compared with the gold standard (CT scan result) to determine the accuracy of the SENSE Device as classifying TBI patients with and without intracranial hemorrhage correctly.
Conditions Studied
Interventions
- DEVICE SENSE device
Study Locations (6)
Texas
- UT Houston - Houston
- UTSA - San Antonio
Florida
- University of Florida - Gainesville
Ohio
- University of Cincinnati - Cincinnati
Pennsylvania
- University of Pittsburgh - Pittsburgh
South Carolina
- MUSC - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-07-11 |
| Est. Completion | 2026-06-30 |
What NCT06828107 shows while recruiting
NCT06828107 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which SENSE device is the first listed.
NCT06828107 lists 6 locations in 5 states (Texas, Florida, Ohio).
Frequently Asked Questions
What is clinical trial NCT06828107 about?
NCT06828107 is a clinical study titled "A Study to Evaluate the SENSE Device's Ability to Detect TBI". 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 b...
What is the current status of trial NCT06828107?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2025-07-11. Estimated completion is 2026-06-30.
What conditions does trial NCT06828107 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT06828107?
The interventions under investigation include: SENSE device (DEVICE).
Who is sponsoring clinical trial NCT06828107?
This trial is sponsored by Sense Diagnostics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06828107 being conducted?
This trial has 6 study locations across Florida, Ohio, Pennsylvania, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06828107's enrollment target sits among peer trials
150 45th of 171 higher than 125 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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