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Diagnostic Test

NeuralBot Investigational System/TTE Std of Care for Stroke (BUBL Trial)

N/A
Waitlist Available
Led By Mark Rubin, MD
Research Sponsored by NovaSignal Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 60 days after subject receives robotic transcranial doppler ultrasound bubble exam
Awards & highlights

Summary

This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD and standard of care TTE to screen for right to left shunt (RLS) or patent foramen ovale (PFO). Additionally, up to 150 evaluable subjects will be evaluated with NB-IS TCD and standard of care TEE.

Eligible Conditions
  • Stroke
  • Mini Stroke
  • Atrial Septal Defect
  • Patent Foramen Ovale

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 60 days after subject receives robotic transcranial doppler ultrasound bubble exam
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 60 days after subject receives robotic transcranial doppler ultrasound bubble exam for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device)
Secondary outcome measures
Percent agreement for detection of clinically significant shunts with robotic TCD vs TTE
Ultrasonography, Doppler, Transcranial
Percent detection of RLS/PFO compared to SOC Transesophageal Echocardiography

Trial Design

1Treatment groups
Experimental Treatment
Group I: NeuralBot Investigational System/TTE Std of CareExperimental Treatment2 Interventions
Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transthoracic Echocardiography (TTE)
2014
N/A
~310
NeuralBot Investigational System
2020
N/A
~160

Find a Location

Who is running the clinical trial?

NovaSignal Corp.Lead Sponsor
2 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Stroke
27 Patients Enrolled for Stroke
Andrei Alexandrov, MDStudy ChairThe University of Tennessee Health Science Center
1 Previous Clinical Trials
1 Trials studying Stroke
Mark Rubin, MDPrincipal InvestigatorThe University of Tennessee Health Science Center
~31 spots leftby Sep 2025
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