N/A
N=154
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Embolic Stroke of Undetermined Source · Transient Ischemic Attack · Right-To-Left Atrial Shunt · Patent Foramen Ovale
Bottom Line
View on ClinicalTrials.gov: NCT04604015 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) — 74; 47; 24; 97 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NeuralBot Investigational System (Diagnostic_test); Transthoracic Echocardiography (TTE) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NovaSignal Corp.
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) |
74; 47; 24; 97 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria TTE Main Study:
- Subject 18 years of age and older.
- Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, include embolic stroke or transient ischemic attack (TIA) in the differential diagnosis.
- Scheduled for a transthoracic echocardiograph (TTE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent.
- Subject is able to successfully perform a Valsalva Maneuver (VM).
- Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.
Exclusion Criteria TTE Main Study:
- Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure.
- Female who is pregnant or lactating at time of admission
- Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months.
- Subjects who have a physical limitation preventing TCD headset placement
Inclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled):
- Subject 18 years of age and older.
- Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, include embolic stroke or TIA in the differential diagnosis.
- Scheduled for a transesophageal echocardiograph (TEE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent.
- Subject is able to successfully perform a Valsalva Maneuver (VM).
- Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.
Exclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled):
- Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure.
- Female who is pregnant or lactating at time of admission
- Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months.
- Subjects who have a physical limitation preventing TCD headset placement.
Data sourced from ClinicalTrials.gov (NCT04604015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.