A Study to Test the SENSE Device in Military-Age Patients... | NCT05155800

Studies
A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury

NCT05155800

Sponsor

Sense Diagnostics, LLC

Status

Completed

Last Update Posted

Nov 22, 2023Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Traumatic Brain Injury

Interventions

SDx3

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2021Actual

Primary Completion Date

Oct 17, 2023Actual

Completion Date

Nov 15, 2023Actual

First Submitted Date

Nov 12, 2021

First Submission Date that Met QC Criteria

Nov 30, 2021

First Posted Date

Dec 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2023

Last Update Posted Date

Nov 22, 2023Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Label	Type	Description	Intervention Names
TBI patients with intracranial bleeding			Device: SDx3
TBI patients without intracranial bleeding			Device: SDx3
Control Subjects with normal brain health			Device: SDx3

Name	Type	Description	Arm Group Labels	Other Names
SDx3	Device	The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare ICH in TBI patients to non-ICH control subjects	1. Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls.	up to 12 months
Measure growth of intracranial hemorrhage	2. Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan.	up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who meet all of the following inclusion criteria will be considered candidates for study enrollment:
- Male or female subjects age 22 to 50
- Patients with TBI who have a diagnostic head CT scan within 24 hours of the injury.
- For patients with TBI without intracranial hemorrhage, Glasgow Coma Scale score at enrollment of ≤ 14.
- For patients with TBI, intended clinical monitoring in the hospital setting for at least 6 hours from study enrollment.
- Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian.
- Willingness and ability to comply with schedule for study procedures.
- Control subjects with normal brain health.

Exclusion Criteria:

All subjects meeting any of the following criteria will be excluded from this study:
- Female patients who are pregnant or lactating.
- Known history of seizure or clinical seizure prior to initiating SENSE monitoring.
- Open skull fracture.
- Metallic intracranial clip, coil, or device (such as metallic ICP monitor).
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study.
- Planned placement of an intraventricular catheter after the diagnostic (pre-enrollment) CT.
- Planned withdrawal of care within 24 hours of enrollment.
- Planned intracranial surgery within 24 hours of enrollment.
- Current participation in a medical or surgical interventional clinical trial.
- Planned or current use of continuous EEG monitoring.
- Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Grady		Atlanta	Georgia	30303	United States
UC Health

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases