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Early Feasibility Study of the SENSE Device

NCT03827720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-02

No results posted yet for this study

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

Interventions

DEVICE

SENSE Device

Non-invasive radiofrequency (RF) sensor

Sponsors & Collaborators

  • Sense Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Andrew Ringer, MD · TriHealth Hatton Research Institute - Good Samaritan Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2020-11-19
Completion
2021-01-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03827720 on ClinicalTrials.gov