Effect of Low Frequency Ultrasound on Kidney Function

April 20, 2021 updated by: Sonogenix

Evaluation of the Effect of Low Frequency Therapeutic Ultrasound (LOTUS) on Kidney Function in Chronic Kidney Disease

The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • Department of Radiology and Biomedical Imaging, UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be >/= 18 years of age
  • Must have documented Stage 3 to Stage 4 (eGFR 15 - 59) chronic kidney disease
  • Females with childbearing potential must not be pregnant at the time of study
  • Subject must provide written informed consent

Exclusion Criteria:

  • Unable or unwilling to cooperate with study procedures
  • Currently enrolled in another clinical study for which the follow-up period is not complete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low Frequency Therapeutic Ultrasound
Low Frequency Therapeutic Ultrasound (LOTUS) applied transcutaneously
Device: Low Frequency Therapeutic Ultrasound
29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular Filtration Rate (GFR)
Time Frame: Baseline and 15 minutes after start of Intervention
Absolute change in glomerular filtration rate, GFR, measured by Tc-99m DTPA (diethylenetriamine pentaacetic acid) imaging (Gates Method) in the treated kidney(s) from baseline to during LOTUS
Baseline and 15 minutes after start of Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in GFR
Time Frame: Baseline and 15 minutes after start of Intervention
Percent change in GFR in the treated kidney(s) from baseline to during LOTUS.
Baseline and 15 minutes after start of Intervention
Blood Pressure
Time Frame: Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention
Blood pressure is measured at baseline, during LOTUS intervention, and immediately after LOTUS intervention
Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous Injury
Time Frame: 5 minutes after LOTUS intervention
Occurrence of cutaneous injury, such as erythema, blistering or rash occuring below the site of transducer placement
5 minutes after LOTUS intervention
Heart rate
Time Frame: Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention.
Heart rate will be measured at baseline, during LOTUS intervention, and immediately after LOTUS intervention has ended.
Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonogenix

Investigators

  • Principal Investigator: Randall A Hawkins, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 28, 2014

Primary Completion (ACTUAL)

October 6, 2014

Study Completion (ACTUAL)

October 6, 2014

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (ESTIMATE)

January 3, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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