Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877847
Status:
TERMINATED
Last Update Posted:
2023-04-12
First Post:
2021-04-27
Brief Title:
Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury
Sponsor:
Sonogenix
Organization:
Sonogenix
Study Overview
Official Title:
Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOTUS
Brief Summary:
Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure
Detailed Description:
This is a multi-center randomized controlled clinical trial designed to assess the safety and performance of the Sonogenix RENOBOOST as an adjunctive therapy for maintaining renal function after contrast exposure The trial will enroll up to 234 subjects not taking oral nitrates and at high-risk of developing PC-AKI undergoing coronary arteriography for a planned percutaneous coronary intervention in up to 10 clinical sites in the US and up to 3 clinical sites outside the US
All subjects will be pre- treated with 09 percent NaCl at 3 mlkgh 1 hour before and 1 mlkgh during and 6 hours post procedure Participants will be randomized in a 21 fashion to either active adjunctive therapy with the Sonogenix RENOBOOST or sham control
Subjects will have clinical follow-up examination 30 days post index procedure
All subjects will be pre- treated with 09 percent NaCl at 3 mlkgh 1 hour before and 1 mlkgh during and 6 hours post procedure Participants will be randomized in a 21 fashion to either active adjunctive therapy with the Sonogenix RENOBOOST or sham control
Subjects will have clinical follow-up examination 30 days post index procedure
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?:
None
Is an FDA AA801 Violation?:
None