RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of R… (NCT04604015) | Clinical Trial Compass
CompletedNot Applicable
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
United States154 participantsStarted 2020-10-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✕. 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
✕. 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.
What they're measuring
1
Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device)
. 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).