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Low-frequency therapeutic ultrasound (LOTUS) for Contrast-induced Nephropathy (LOTUS Trial)
LOTUS Trial 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
LOTUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LOTUS Trial Design
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Who is running the clinical trial?
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."
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."
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."
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"
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