CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
SENSE Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03038087
NCT03038087N/ACompleted
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An Early Feasibility Study to Evaluate the User Interfaces and Sensitivity of the SENSE Device in Patients With Intracranial Hemorrhage

Sense Diagnostics, LLC·interventional·Posted Jan 31, 2017·Updated Dec 7, 2021

In Brief

A clinical study evaluating SENSE Device for Intracerebral Hemorrhage and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The purpose of this research study is to find out whether a device for monitoring bleeding in patients with acute hemorrhagic stroke will show similar findings as CT scans performed to evaluate the stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntracerebral Hemorrhage, Stroke, Acute, Stroke Hemorrhagic
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartFeb 23, 2017
Primary CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.4 years ago

Interventions

SENSE Devicedevice

The SENSE device transmits a low power tailored electro-magnetic pulse across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts: 1. A molded plastic headpiece containing the antenna array, and 2. A processing control unit. The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.