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RECRUITING

A Study to Evaluate the SENSE Device's Ability to Detect TBI

NCT06828107 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2025-07-11
Est. Completion 2026-06-30

Sponsor

Sense Diagnostics

28 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06828107

The ClinicalTrials.gov registry entry for NCT06828107 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sense Diagnostics, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06828107 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06828107?

The interventions under investigation include: SENSE device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06828107?

This trial is sponsored by Sense Diagnostics, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial