Skip to main content
OpenTrials
Completed

NCT Number: NCT02026544

Effect of Low Frequency Ultrasound on Kidney Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiology and Biomedical Imaging, UCSF

San Francisco, California, 94107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Frequency Therapeutic Ultrasound

Device

29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Sonogenix

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2014
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.