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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

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