Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage

Traumatic Brain Injury Clinical Trial

Official title:

A Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study to Evaluate the SENSE Device's Ability to Detect Intracranial Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642443
• Other study ID #: SENSE-003
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Sense Diagnostics, LLC
• Contact: Alex Hall, BSN
• Phone: 404-778-1585
• Email: alex.hall[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH or traumatic intracranial bleeding for the detection and monitoring of intracranial hemorrhages.

Description:

This study is a two-stage, pivotal, prospective, nonrandomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scans. All subjects who meet eligibility criteria should be enrolled. An algorithm has been developed for detecting ICH, which will now be tested in this independent cohort of subjects. CT scans will be grouped into: 1) ICH, or 2) non- ICH. Enrollment will continue until 120 subjects with and 120 without ICH have been enrolled. An interim analysis will occur after ~60 subjects each with and without ICH have been enrolled and the sample size may be increased at the direction of the DMC as warranted. In Stage 1, 150 subjects (with primary spontaneous ICH or traumatic intracranial hemorrhage) were enrolled for the development of a hemorrhage detection algorithm. In Stage 2, the algorithm developed in Stage 1 will be tested in an independent cohort of up to 300 subjects. All subjects who meet eligibility criteria should be enrolled. The gold standard will be the CT results. The algorithm established in Stage 1 will be tested in this independent cohort of subjects. CT scans will be grouped into: 1) ICH or, 2) non-ICH. Enrollment will continue until ~60 subjects each with and without ICH have been enrolled. An interim analysis will occur after ~60 subjects each with and without ICH have been enrolled and the sample size may be increased at the direction of the DMC as warranted. All subjects' CT images will be reviewed by an independent neuroradiology core for classification as ICH or non-ICH, and ICH volume estimation. The treating clinicians and independent neuroradiologist will be blinded to the SENSE device findings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients age 22 years and older
• CT obtained in the mobile stroke unit, emergency department (ED) or hospital

Exclusion Criteria:

• Female patients who are pregnant or lactating
• SENSE device cannot be applied within 6 hours of a standard of care CT,
• Metallic intracranial clip, coil, device (such as ICP monitor), or penetrating metallic shrapnel,
• Metallic EEG leads in place at the time of planned enrollment,
• Open skull fracture (closed skull fracture is not an exclusion),
• Placement of an intraventricular catheter prior to enrollment, Hemorrhagic transformation of ischemic stroke,) as etiology of ICH,
• Treatment with intravenous thrombolysis or embolectomy prior to enrollment,
• Clinical uncertainty about whether intracranial hemorrhage is present on the pre-enrollment head CT, and
• Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for SENSE device monitoring or study participation or may confound the outcome of the study.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhage
• Intracranial Hemorrhages
• Traumatic Brain Injury

Intervention

Device:
• SENSE Device
The SENSE Device is indicated for the monitoring of intracranial hemorrhage by detecting a suspected increase in blood volume within the cranial vault. It is an adjunctive device to the clinical evaluation in the acute hospital setting of patients 22 years of age or older with suspected or known intracranial hemorrhage. The device is indicated for use to monitor patients for intracranial hemorrhage expansion between CT scans but should not serve as a substitute for these scans.

Locations

Country	Name	City	State
United States	Grady	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Sense Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	Detection of ICH is the primary endpoint for this study. To establish the sensitivity (primary) and specificity (key secondary) for ICH detection. The results from the CT (ICH versus no ICH) scan will serve as the gold standard.	24-hours