Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604015
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2020-10-22
Brief Title:
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Sponsor:
NovaSignal Corp
Organization:
NovaSignal Corp
Study Overview
Official Title:
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUBL
Brief 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None