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

About this trial

Last updated 3 years ago

Study ID

SENSE-003

Status

Unknown

Type

Interventional

Phase

N/A

Placebo

Accepting

22+ Years

All Sexes

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

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.