Energy Ramping Versus Fixed Dose ESWL

NCT07334236 — Not applicable, Not yet recruiting, 100 participants, mohammed Abdelhafez

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

Registry	NCT07334236
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	100 (Estimated)
Sponsor	mohammed Abdelhafez (Other)
Conditions	Renal Calculi
Interventions	Extracorporeal shock wave lithotripsy (Procedure)
Dates	start 2026-01-03 (estimated), primary completion 2026-06-01 (estimated), completion 2026-11-01 (estimated), first posted 2026-01-12, last updated 2026-01-12
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
fixed-dose ESWL	Active comparator	Procedure: Extracorporeal shock wave lithotripsy	* Start therapeutic/high energy (e.g., 80-100% device max) from therapeutic phase. * Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks and cumulative energy.
escalating-dose ESWL	Experimental	Procedure: Extracorporeal shock wave lithotripsy	* Stepwise escalation: increase energy every 500-1000 shocks (example: 20% → 40% → 60% → 80-100%) until therapeutic energy reached. * Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks per step and cumulative energy.

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.

+Outcome measures

Primary outcomes

Stone free rate [4 weeks]: Proportion of participants achieving complete stone clearance as confirmed by imaging (ultrasound or CT).

Secondary outcomes

Number of ESWL sessions to achieve SFR. [4 weeks]

+Eligibility

Sex: All, ages: any to 80 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Sohag university Hospital	Sohag	Egypt