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Diagnostic Device

SENSE Device for Detecting Brain Bleeds

N/A

Recruiting

Led By Jonathan Ratcliff, MD

Research Sponsored by Sense Diagnostics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients age 22 years and older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-hours

Awards & highlights

Study Summary

This trial is testing a new device, SENSE, to see if it is better than a standard CT scan for detecting and monitoring brain bleeds.

Who is the study for?

This trial is for men and women aged 22 or older who have had a CT scan due to spontaneous or traumatic intracranial bleeding. It's not for pregnant or breastfeeding women, those with metallic brain implants, open skull fractures, certain prior treatments like thrombolysis, or if the SENSE device can't be used within 6 hours of their CT scan.Check my eligibility

What is being tested?

The study tests the SENSE device's effectiveness in detecting and monitoring brain bleeds compared to standard head CT scans. Participants will use both methods so researchers can compare results directly in this non-randomized trial across multiple centers.See study design

What are the potential side effects?

Since the SENSE device is a diagnostic tool rather than a treatment, it may not have direct side effects like medications do. However, there could be discomfort from wearing the device or potential skin irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 22 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Trial Design

2Treatment groups

Active Control

Group I: Traumatic Brain InjuryActive Control1 Intervention

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: A molded plastic headpiece containing the antenna array An intermediate control unit that contains: a. The driving electronics for the array of antennae A processing control unit that contains: A spectrum analyzer The operating software that controls the device function and data acquisition, processing and archiving. The user interface for inputting patient information and displaying the output of the data

Group II: Intracranial HemorrhageActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sense Diagnostics, LLCLead Sponsor

3 Previous Clinical Trials

105 Total Patients Enrolled

Jonathan Ratcliff, MDPrincipal InvestigatorEmory University

1 Previous Clinical Trials

75 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Recent research and studies

clinicaltrials.govStudy

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

2020. "Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04642443.

~21 spots leftby Jun 2024

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