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

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury; Intracranial Hemorrhages
• Interventions: Device: SENSE Device

• Registration Number: NCT04642443
• Lead Sponsor: Sense Diagnostics, LLC

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-24
• Study Start: 2020-12-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracranial Hemorrhage	SENSE Device	The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of three parts: 1. A molded plastic headpiece containing the antenna array 2. An intermediate control unit that contains: a. The driving electronics for the array of antennae 3. A processing control unit that contains: 1. A spectrum analyzer 2. The operating software that controls the device function and data acquisition, processing and archiving. 3. The user interface for inputting patient information and displaying the output of the data
Traumatic Brain Injury	SENSE Device	The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of three parts: 1. A molded plastic headpiece containing the antenna array 2. An intermediate control unit that contains: a. The driving electronics for the array of antennae 3. A processing control unit that contains: 1. A spectrum analyzer 2. The operating software that controls the device function and data acquisition, processing and archiving. 3. The user interface for inputting patient information and displaying the output of the data

Primary Outcome Measures

Name	Time	Method
Primary Outcome	24-hours	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.

Trial Locations

Locations (1)

Grady; 🇺🇸 Atlanta, Georgia, United States