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Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury

NCT04877847 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-04-12

No results posted yet for this study

Summary

Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.

Conditions

  • Contrast-induced Nephropathy
  • Chronic Kidney Diseases

Interventions

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.

Sponsors & Collaborators

  • Sonogenix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2023-01-23
Completion
2023-01-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877847 on ClinicalTrials.gov