Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-14
Brief Title:
Cardiac Interventional ICE Imaging Trial
Sponsor:
ICE Intelligent Healthcare Co Ltd
Organization:
ICE Intelligent Healthcare Co Ltd
Study Overview
Official Title:
The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
INTELICE
Brief Summary:
The INTELICE trial is a prospective multicenter 11 randomized controlled non-inferiority study It aims to compare a novel intracardiac echography ICE catheter and combined ultrasound system with existing commercial ones The evaluation will be conducted on patients undergoing planned intracardiac interventional process
Detailed Description:
This randomized controlled trial will enroll adult patients undergoing cardiac interventions who will be randomly assigned to either the experimental device group or the control group
The main endpoint of the INTELICE trial is the image quality rate of intracardiac echocardiography which will be evaluated by three experienced sonographers from the core laboratory while the operators image quality assessment serves as a secondary endpoint In addition secondary endpoints include clinical success rate technical success rate procedure time and evaluation for the experimental devices
The main endpoint of the INTELICE trial is the image quality rate of intracardiac echocardiography which will be evaluated by three experienced sonographers from the core laboratory while the operators image quality assessment serves as a secondary endpoint In addition secondary endpoints include clinical success rate technical success rate procedure time and evaluation for the experimental devices
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?:
None
Is an FDA AA801 Violation?:
None