RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Completed · Not applicable
Conditions studied: Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale
In brief
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.
Key facts
- Study ID
- NCT04604015
- Run by
- NeuraSignal Inc dba NovaSignal
- People needed
- 154
- Starts
- 2020-10-06
- Expected to finish
- 2021-11-02
- Last updated by the study team
- 2024-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- Providence Brain & Spine Institute — Portland, Oregon, United States
- Providence St. Vincent Medical Center — Portland, Oregon, United States
- CHI Memorial Hospital — Chattanooga, Tennessee, United States
- The University of Tennessee Health Science Center — Memphis, Tennessee, United States
- Houston Methodist Neurological Institute — Houston, Texas, United States
- Swedish Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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