Effect of Low Frequency Ultrasound on Kidney Function

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02026544

Enrollment

Registered

2014-01-03

Start date

2014-01-28

Completion date

2014-10-06

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

low frequency ultrasound, glomerular filtration rate

Brief summary

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.

Interventions

DEVICELow Frequency Therapeutic Ultrasound

29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Glomerular Filtration Rate (GFR)	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

Secondary

Measure	Time frame	Description
Percent change in GFR	Baseline and 15 minutes after start of Intervention	Percent change in GFR in the treated kidney(s) from baseline to during LOTUS.
Blood Pressure	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

Other

Measure	Time frame	Description
Heart rate	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.
Cutaneous Injury	5 minutes after LOTUS intervention	Occurrence of cutaneous injury, such as erythema, blistering or rash occuring below the site of transducer placement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026