Early Feasibility Study of the SENSE Device

NCT03827720 | Completed FDA Device

• 1 other identifier: SENSE-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset.

Conditions

Hemorrhagic Stroke; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Correlation of SENSE signal with CT scan for stroke severity (location), hemorrhage volume (ABC method) and AIS LOV status (presence and location)

  The change in received power (PR) measured by the SENSE device will be calculated and the accuracy of the SENSE algorithm will be tested for the SENSE measurement that correspond with diagnostic CT scan for stroke severity, hemorrhage volume and in the case of AIS, presence or absence of LVO..

  45 minutes

Secondary Outcomes (2)

• Number of participants that completed the 45 mins monitoring session with the Sense Device successfully through confirmation that all planned data has been collected.

  45 minutes

• Number of participants with adverse events (AE), unanticipated adverse device effects (UADE) and serious adverse events (SAE) as defined in the protocol.

  7 days

Study Arms (4)

Control

EXPERIMENTAL

Healthy volunteers monitored with Sense Device

Device: SENSE Device

Intracranial Hemorrhage

EXPERIMENTAL

Intracranial hemorrhage patients monitored with Sense Device

Device: SENSE Device

Acute Ischemic Stroke with LOV

EXPERIMENTAL

Acute Ischemic Stroke patients that have large vessel occlusion monitored with SENSE Device

Device: SENSE Device

AIS without LOV

EXPERIMENTAL

Ischemic Stroke patients that do not have large vessel occlusion monitored with SENSE device

Device: SENSE Device

Interventions

SENSE Device DEVICE

Non-invasive radiofrequency (RF) sensor

Also known as: CT Scan

AIS without LOV; Acute Ischemic Stroke with LOV; Control; Intracranial Hemorrhage

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients age 22 years and older
• Established diagnosis of AIS (with or without LVO) or ICH within 24 hours of symptom onset
• Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian
• Willingness and ability to comply with 45 minutes of SENSE monitoring per study procedures
• Attending (Treating) physician has indicated that the patient is stable and has approved the patient's participation in the study

You may not qualify if:

• Female patients who are pregnant or lactating
• Patients with a known seizure disorder or those who have a seizure at stroke onset
• Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study
• Intraventricular hemorrhage requiring emergent ventriculostomy placement on the eligibility CT or MRI
• Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
• Pontine or infratentorial location of ICH
• In AIS patients, treatment with intravenous alteplase and/or mechanical thrombectomy prior to the initiation of 45 minutes of SENSE monitoring
• Current participation in an interventional clinical trial

Sponsors & Collaborators

• Sense Diagnostics, LLC: lead

Study Sites (2)

TriHealth Hatton Research Institute - Good Samaritan Hospital

Cincinnati, Ohio, 45212, United States

Location

UC Health

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Hemorrhagic Stroke; Ischemic Stroke

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Andrew Ringer, MD

  TriHealth Hatton Research Institute - Good Samaritan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The Sensor Evaluation of Neurologic Status in Emergencies (SENSE) device (Sense Diagnostics LLC; Cincinnati, OH) is a non-invasive radiofrequency (RF) sensor that detects and monitors intracranial hemorrhage (ICH).

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 1, 2019
• Study Start: June 6, 2019
• Primary Completion: November 19, 2020
• Study Completion: January 4, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-07

Locations

US (2)