Low-frequency therapeutic ultrasound (LOTUS) for Contrast-induced Nephropathy
Study Summary
This trial will study whether low-frequency therapeutic ultrasound is safe and effective for preserving kidney function after contrast exposure.
- Contrast-induced Nephropathy
- Chronic Kidney Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: through baseline procedure
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Low-Frequency Therapeutic Ultrasound
1 of 2
Sham Control
1 of 2
Experimental Treatment
Non-Treatment Group
234 Total Participants · 2 Treatment Groups
Primary Treatment: Low-frequency therapeutic ultrasound (LOTUS) · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are new participants being sought for this trial currently?
"Affirmative. Clinicaltrials.gov data indicates that the study, which was first unveiled on September 24th 2021, is currently enrolling participants. This trial requires 234 volunteers to be recruited between 4 distinct sites." - Anonymous Online Contributor
What is the aggregate amount of participants in this clinical experiment?
"To facilitate this experiment, 234 individuals that meet the inclusion criteria need to be identified. Sonogenix is responsible for running proceedings out of multiple healthcare institutions including McLaren Northern Michigan in Petoskey and Henry Ford Hospital in Detroit." - Anonymous Online Contributor
How many healthcare facilities are involved in administering this trial?
"Patients are currently being enrolled in this trial at McLaren Northern Michigan, Henry Ford Hopsital and University of Pennsylvania Medical Center. Additionally, there is an extra 4 sites available for enrollment." - Anonymous Online Contributor
What goals is this trial attempting to accomplish?
"The primary metric that will be evaluated over a two-day period is the Primary Safety Endpoint. Secondary endpoints include: Stage 1 - Serum Creatinine 1.5-1.9 times baseline or greater than or equal to 0.3 mg/dL increase, Stage 2 - Serum Creatinine 2-2.9 times baseline, Stage 3 - Serum Creatinine 3 times baseline or Increase in serum creatinine to greater than or equal to 4 mg/dL or Initiation of renal replacement therapy, Incidence of Post Contrast Acute Kidney Injury which is defined as defined as greater than" - Anonymous Online Contributor