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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03827720
Other study ID # SENSE-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2019
Est. completion date January 4, 2021

Study information

Verified date July 2021
Source Sense Diagnostics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
SENSE Device
Non-invasive radiofrequency (RF) sensor

Locations

Country Name City State
United States TriHealth Hatton Research Institute - Good Samaritan Hospital Cincinnati Ohio
United States UC Health Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Sense Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of participants that completed the 45 mins monitoring session with the Sense Device successfully through confirmation that all planned data has been collected. The ability to process collected data in a manner that allows application and use of the SENSE device in a clinical environment through assessment of all participants that have complete SENSE Device data. 45 minutes
Secondary Number of participants with adverse events (AE), unanticipated adverse device effects (UADE) and serious adverse events (SAE) as defined in the protocol. Preliminary estimate of the safety of the device when used in a clinical setting through tabulation and summary of AEs, UADEs and SAEs. 7 days
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