Energy Ramping Versus Fixed Dose ESWL

ConditionRenal Calculi

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 80

Sponsormohammed Abdelhafez

About this trial

This clinical trial compares two techniques of extracorporeal shock wave lithotripsy (ESWL) - energy ramping versus fixed dose - in adult patients with renal stones. The study aims to evaluate stone-free rates, retreatment needs, and safety outcomes across multiple clinical sites in Egypt.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults ≥18 years.

Radiopaque renal or proximal/mid ureteral stone ≤20 mm.

eGFR ≥60 mL/min/1.73 m².

Fit for ESWL.

Disqualifiers

• Pregnancy.

Active, untreated UTI.

Uncorrected bleeding disorder or anticoagulation that cannot be stopped.

Prior ipsilateral renal surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

Extracorporeal shock wave lithotripsy
Procedure/Surgery
Fixed Voltage (experimental): Subjects receive shock wave therapy at a constant energy level (e.g., 20-22 kV) for the entire duration of the session. Standard delivery includes approximately 3,000 shocks at a frequency of 60-90 shocks per minute. Voltage Ramping (control): Subjects receive shock wave therapy starting at a low energy level (e.g., 6-10 kV) for an initial "priming" phase of 100-500 shocks. Energy is then escalated in predefined increments (e.g., 1-2 kV every 250-500 shocks) until reaching the target therapeutic voltage.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: fixed-dose ESWLActive comparator 1 intervention

Group B: escalating-dose ESWLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Stone free rate

Proportion of participants achieving complete stone clearance as confirmed by imaging (ultrasound or CT).

Time frame

4 weeks

Secondary outcomes

Number of ESWL sessions to achieve SFR.

Time frame

4 weeks

Sponsors and contacts

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mohammed Abdelhafez

Lead sponsor

Sohag University

Sponsor institution

Source ClinicalTrials.gov

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