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Ultrasound Therapy

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

N/A
Waitlist Available
Research Sponsored by Sonogenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 96 hours after contrast exposure
Awards & highlights

LOTUS Trial 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

LOTUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through baseline procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and through baseline procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint
Primary Safety Endpoint
Secondary outcome measures
Absolute and percent-change in estimated glomerular filtration rate (eGFR)
Hospitalization
Incidence of Post Contrast Acute Kidney Injury
+5 more

LOTUS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-Frequency Therapeutic UltrasoundExperimental Treatment1 Intervention
LOTUS system will be operated per operated per normal instructions
Group II: Sham ControlPlacebo Group1 Intervention
LOTUS system will be set to Control setting

Find a Location

Who is running the clinical trial?

SonogenixLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~1 spots leftby Apr 2025