Low-frequency therapeutic ultrasound (LOTUS) for Contrast-induced Nephropathy

Phase-Based Progress Estimates
UT Health San Antonio, San Antonio, TXContrast-induced Nephropathy+1 MoreLow-frequency therapeutic ultrasound (LOTUS) - Device
All Sexes
What conditions do you have?

Study Summary

This trial will study whether low-frequency therapeutic ultrasound is safe and effective for preserving kidney function after contrast exposure.

Eligible Conditions
  • Contrast-induced Nephropathy
  • Chronic Kidney Disease

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: through baseline procedure

30 days
Primary Safety Endpoint
48 hours
Primary Efficacy Endpoint
Day 30
Intensive Care
Day 30
Hour 96
Absolute and percent-change in estimated glomerular filtration rate (eGFR)
through baseline procedure
Total urine output
Hour 96
Maximum percent-change
Hour 96
Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)
Hour 96
Incidence of Post Contrast Acute Kidney Injury
Incidence of contrast-induced nephropathy

Trial Safety

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

Low-Frequency Therapeutic Ultrasound
Experimental Group · 1 Intervention: Low-frequency therapeutic ultrasound (LOTUS) · Intervention Types: Device
Sham Control
ShamComparator Group · 1 Intervention: LOTUS System with Ultrasound Disabled · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through baseline procedure

Who is running the clinical trial?

SonogenixLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.