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RECRUITING
NCT06194591
NA

Nephrospec Switzerland

Sponsor: Menno Pruijm

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind sham-controlled monocentric trial. 30 patients that are diagnosed with hypertension and with moderate to severe chronic kidney disease are included in this trial. 20 of them are randomized into the active treatment arm, 10 into the sham arm. Low-intensity extracorporal shock wave (Li-ESWT) sessions (arm1) or sham sessions (arm2), will be administered with a dedicated probe within three consecutive weeks to the kidneys of patients.The study will add data to the effects of the shock wave treatment on blood pressure and will assess whether this treatment improves renal function, perfusion and oxygenation. The study includes a third arm (arm3) in which treatment sessions are administered to patients that were in the placebo group in the first phase of the study (arm2).

Official title: Low-intensity Extracorporeal Shockwave Therapy With the Nephrospec TM Device for the Treatment of Hypertension in Patients Diagnosed With Chronic Kidney Disease (CKD) : a Randomized, Double-blind Sham-controlled Monocentric Trial

Key Details

Gender

All

Age Range

18 Years - 82 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-02-19

Completion Date

2029-06-30

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DEVICE

NephrospecTM, low-intensity extracorporal shockwave therapy device

Patients will receive 6 Li-ESWT treatments with the NephrospecTM device over three consecutive weeks, with a minimal recess of 24 hours between treatments and a maximum of 3 sessions per week. Three hundred shockwaves will be applied by the PI or co-PI to each one of 8 pre-selected regions of each kidney, under ultrasound control, with the patient in the prone position. No local anaesthesia is needed. Total treatment time of one session is 30 minutes. The participant will remain under supervision for another 30 minutes and will be discharged hereafter.

DEVICE

Sham-Device

The sham device is the NephrospecTM applicator with an internal barrier to prevent shockwaves to pass through to the patient.

Locations (1)

Department of Nephrology, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland