Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650839
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
POC for the Treatment of Subjects With Moderate AS Using Valvosoft Non-Invasive Ultrasound Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Proof of Concept Clinical Investigation for the Treatment of Subjects With Moderate Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy
Detailed Description:
Valvosoft Ultrasound guided Non-Invasive Ultrasound Therapy NIUT medical device delivers focused and controlled short ultrasound pulses 20μsec directed trans-thoracically at a high acoustic intensity measured in watts per square centimeter Wcm2 to produce non-thermal mechanical tissue softening of the targeted calcified aortic valve
Echocardiographic live imaging enables to follow valve movements in real-time and thus target the therapeutic ultrasound on the calcified valve with great precision This is first in human or proof of concept study
Echocardiographic live imaging enables to follow valve movements in real-time and thus target the therapeutic ultrasound on the calcified valve with great precision This is first in human or proof of concept study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None