Finished
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
NCT04604015 · NeuraSignal Inc dba NovaSignal · Updated 24 Jan 2024
- What is being tested
- NeuralBot Investigational System; Transthoracic Echocardiography (TTE)
- For
- Embolic Stroke of Undetermined Source; Transient Ischemic Attack; Right-To-Left Atrial Shunt; Patent Foramen Ovale
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 154 people. The full rules are on the registry page.
- Where
- United States (7 sites)
- When
- Starts or started 6 Oct 2020, ends 2 Nov 2021. Registered 27 Oct 2020.
- Results
- Posted on the registry on 24 Jan 2024.
In the researchers' words
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.
Sites
- Barrow Neurological InstitutePhoenix, Arizona, United States
- Providence Brain & Spine InstitutePortland, Oregon, United States
- Providence St. Vincent Medical CenterPortland, Oregon, United States
- CHI Memorial HospitalChattanooga, Tennessee, United States
- The University of Tennessee Health Science CenterMemphis, Tennessee, United States
- Houston Methodist Neurological InstituteHouston, Texas, United States
- Swedish HospitalSeattle, Washington, United States