RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 7
- 主要终点
- Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device)
研究概览
简要总结
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.
详细描述
The objectives of the study is to evaluate the shunt detection rate of the NeuralBot Investigational System (NB-IS) TCD relative to standard of care diagnostic techniques (transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and standard transcranial Doppler ultrasound (TCD) and to assess the safety, accuracy and usability of the NB-IS device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
All de-identified imaging data will be sent to a core laboratory which will provide independent quantitative and qualitative assessment of all NB-IS TCD and Standard of care (SOC) TCD, TTE, and TEE bubble study data. They will be blinded to the study and local diagnostic report data and provide independent review. The Core Lab interpretations will supersede all local interpretations and will be applied to all study endpoint analyses as applicable.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NeuralBot Investigational System/TTE Std of Care
Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care
干预措施: NeuralBot Investigational System (Diagnostic Test)
NeuralBot Investigational System/TTE Std of Care
Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care
干预措施: Transthoracic Echocardiography (TTE) (Diagnostic Test)
结局指标
主要结局
Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device)
时间窗: 1 day
The primary outcome measure was the percent detection of Right to Left Shunt using the robotic assisted TCD (study device) and compare it to the percent detection of Right to Left Shunt using standard of care Transthoracic Echocardiography (TTE) for the same patient cohort. The detection of the Right to Left Shunt included site and independent Core Lab assessment of TTE.
次要结局
未报告次要终点