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NCT02026544 Clinical Trial

Effect of Low Frequency Ultrasound on Kidney Function

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02026544
Other study ID # PRO-0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 28, 2014
Est. completion date October 6, 2014

Study information
Verified date April 2021
Source Sonogenix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date October 6, 2014
Est. primary completion date October 6, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Low Frequency Therapeutic Ultrasound
29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously

Locations
Country Name City State
United States Department of Radiology and Biomedical Imaging, UCSF San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Sonogenix

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dae MW, Liu KD, Solomon RJ, Gao DW, Stillson CA. Effect of Low-Frequency Therapeutic Ultrasound on Induction of Nitric Oxide in CKD: Potential to Prevent Acute Kidney Injury. Kidney Dis (Basel). 2020 Nov;6(6):453-460. doi: 10.1159/000509819. Epub 2020 Aug — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Cutaneous Injury Occurrence of cutaneous injury, such as erythema, blistering or rash occuring below the site of transducer placement 5 minutes after LOTUS intervention
Other Heart rate 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.
Primary Glomerular Filtration Rate (GFR) 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 Percent change in GFR Percent change in GFR in the treated kidney(s) from baseline to during LOTUS. Baseline and 15 minutes after start of Intervention
Secondary Blood Pressure 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
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