Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392243
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Brief Title:
IntraCardiac Echocardiography sysTem
Sponsor:
Sonosemi Medical Co Ltd
Organization:
Sonosemi Medical Co Ltd
Study Overview
Official Title:
Prospective Multicenter ranDomized Controlled Non-Inferior Clinical Trial to Evaluate the SafeTy and effIcacy of a Novel intraCardiac Echocardiography sysTemDISTINCT Trial
Status:
COMPLETED
Status Verified Date:
2024-04
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:
DISTINCT
Brief Summary:
To evaluate the safety and effectiveness of intracardiac ultrasound imaging system in Sonosemi Medical Co Ltd
Detailed Description:
A prospective multicenter randomized controlled non-inferiority clinical trial was designed In the experimental group intracardiac and large blood vessel imaging intracardiac Doppler flow assessment and guidance of intracardiac intervention were performed by intracardiac ultrasound imaging system of Sonosemi Medical Co Ltd The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter SNDSTR10G and Vivid IQ intracardiac and macrovascular imaging of the heart assessment of intracardiac Doppler flow and guidance for intracardiac intervention After meeting the entry criteria they will be randomized by an electronic randomization system and the researchers will conduct a clinical trial based on the results of the randomization intracardiac and large vessel imaging intracardiac Doppler flow assessment and guidance of intracardiac intervention were performed in both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None