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NCT Number: NCT07334236

Energy Ramping Versus Fixed Dose ESWL

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.

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Key information

Conditions

Renal Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This multi-center, randomized controlled trial investigates the impact of energy ramping versus fixed-dose ESWL on stone clearance in patients with solitary renal calculi. Participants will be assigned to either a gradually increasing energy protocol or a constant energy protocol using standardized lithotripter settings. The primary outcome is stone-free rate at two weeks post-treatment, assessed via imaging. Secondary outcomes include retreatment rate, pain scores, adverse events, and procedure duration. The study is conducted under IRB approval from Sohag University and follows international ethical standards for human research.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years.
  • Radiopaque renal or proximal/mid ureteral stone ≤20 mm.
  • eGFR ≥60 mL/min/1.73 m².
  • Fit for ESWL.
  • Able to give informed consent and complete follow up.

Exclusion criteria

  • • Pregnancy.
  • Active, untreated UTI.
  • Uncorrected bleeding disorder or anticoagulation that cannot be stopped.
  • Prior ipsilateral renal surgery.
  • Non radio-opaque stone without reliable imaging.
  • Inability to tolerate ESWL or required anesthesia.

Treatment and study plan

Extracorporeal shock wave lithotripsy

Procedure

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.

Primary outcomes

  1. Stone free rate

    Time frame: 4 weeks

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

Secondary outcomes

  1. Number of ESWL sessions to achieve SFR.

    Time frame: 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

mohammed A Abdelhafez

CONTACT

[email protected]

+201143548707

Sponsors and collaborators

Lead sponsor

mohammed Abdelhafez

Other

Registry information

Official study title

Energy Ramping Versus Fixed Dose ESWL on Stone-Free Rate (Comparative Study)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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