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

NCT04642443 | Unknown DMC FDA Device

• 1 other identifier: SENSE-003
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  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.

  24-hours

Study Arms (2)

Intracranial Hemorrhage

ACTIVE COMPARATOR

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

Device: SENSE Device

Traumatic Brain Injury

ACTIVE COMPARATOR

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

Device: SENSE Device

Interventions

SENSE Device 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.

Intracranial Hemorrhage; Traumatic Brain Injury

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Sense Diagnostics, LLC: lead

Study Sites (1)

Grady

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Intracranial Hemorrhages; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jonathan Ratcliff, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Hall, BSN

CONTACT

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

sara m keegan, MEd

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 24, 2020
• Study Start: December 23, 2020
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)