NCT07334236

Energy Ramping Versus Fixed Dose ESWL

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: mohammed Abdelhafez · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Calculi

Interventions

Type	Name	Description
PROCEDURE	Extracorporeal shock wave lithotripsy	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.

Timeline

• Start date: 2026-01-03
• Primary completion: 2026-06-01
• Completion: 2026-11-01
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Egypt