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

Sonogenix1 site in 1 country10 target enrollmentJanuary 28, 2014

ConditionsChronic Kidney Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Kidney Disease
Sponsor: Sonogenix
Enrollment: 10
Locations: 1
Primary Endpoint: Glomerular Filtration Rate (GFR)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 28, 2014

End Date

October 6, 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sonogenix

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Percent change in GFR(Baseline and 15 minutes after start of Intervention)
Blood Pressure(Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention)