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

Phase

N/A

Condition

Memory Loss

Hemorrhage

Traumatic Brain Injury

Treatment

SENSE Device

Clinical Study ID

NCT04642443

SENSE-003

Ages > 22
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 penetratingmetallic 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, Hemorrhagictransformation 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 thepre-enrollment head CT, and
Presence or history of any other condition or finding that, in the investigator'sopinion, makes the patient unsuitable as a candidate for SENSE device monitoring orstudy participation or may confound the outcome of the study.

Study Design

SENSE Device

December 23, 2020

September 30, 2024

Study 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.

Connect with a study center

Grady
Atlanta, Georgia 30303
United States
Active - Recruiting

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