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

Description

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.

Conditions

Intracranial Hemorrhages, Traumatic Brain Injury

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Intracranial Hemorrhages
Intervention / Treatment

-

Contacts and Locations

Atlanta

Grady, Atlanta, Georgia, United States, 30303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sense Diagnostics, LLC,

Jonathan Ratcliff, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2024-09-30