Recruiting

SENSE Device

Sponsor:

Sense Diagnostics, LLC

Code:

NCT04642443

Conditions

Intracranial Hemorrhages

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

SENSE Device

Study Details

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.

Conditions

Intracranial Hemorrhages

Traumatic Brain Injury

Study ID

NCT04642443

Start date

Dec 23, 2020

Status verified date

Sep, 2023

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

450 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Intracranial Hemorrhage

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

active comparator: Traumatic Brain Injury

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

Interventions

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.

Primary outcome measure

  • Primary Outcome [ Time Frame: 24-hours ]

Central Contacts and Locations

Central contacts

Alex Hall, BSN

404-778-1585alex.hall@emory.edu

sara m keegan, MEd

513-584-0470sara.stark@uc.edu

Locations

Grady

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

Jonathan Ratcliff, MD

More Information

Sponsor

Sense Diagnostics, LLC

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sense Diagnostics, LLC on 2023-09-28.