Trials / Terminated
TerminatedNCT04877847
Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury
Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Sonogenix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 0.9 percent NaCl at 3 ml/kg/h 1 hour before and 1 ml/kg/h during and 6 hours post procedure. Participants will be randomized in a 2:1 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Low-frequency therapeutic ultrasound (LOTUS) | Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on per normal operating instructions. |
| DEVICE | LOTUS System with Ultrasound Disabled | Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on and set to Control Setting. |
Timeline
- Start date
- 2021-09-24
- Primary completion
- 2023-01-23
- Completion
- 2023-01-23
- First posted
- 2021-05-07
- Last updated
- 2023-04-12
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04877847. Inclusion in this directory is not an endorsement.