MedTrace Logo

Nephrospec Switzerland

NCT06194591 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-23

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • Menno Pruijm

    lead OTHER

Principal Investigators

  • Menno Pruijm, Dr · CHUV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2028-09-30
Completion
2029-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06194591 on ClinicalTrials.gov