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Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 9, 2025 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Jul 30, 2025 to Mar 30, 2026
    • Site contact updated
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jun 30, 2025 to Jul 30, 2025
    • Study completion date: Jun 30, 2026 to Jul 30, 2026
    • Start date changed from estimate of Jun 20, 2024 to Jul 1, 2024
    • Site details revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The incidence of kidney stones (urolithiasis) has surged in both developing and developed countries, affecting approximately 15% of the global population. From 2010 to 2019, diagnoses of kidney and ureteral stones rose by 8% in Germany, 26% in France, and 15% in England. Correspondingly, the number of surgical stone removal procedures increased by 3%, 38%, and 18%, respectively. Common treatments include extracorporeal shock wave lithotripsy (ESWL), ureterorenoscopy (URS) with lithotripsy, and percutaneous nephrolithotomy (PCNL). URS, depending on stone size, has become a preferred method due to advancements in intraoperative imaging and laser technology. Despite these improvements, small fragments often remain post-intervention, leading to recurrent stones. Complete removal of all fragments is crucial to significantly reduce recurrence rates. Current literature suggests a high recurrence rate with residual fragments, impacting healthcare costs and patient quality of life. A key objective in endourological research is optimizing the stone clearance rate. Techniques like coagulum lithotomy and the autologous blood clot technique have been developed to enhance residual stone removal after laser fragmentation. These methods benefit selected patients but are not widely adopted due to complications such as reduced intraoperative visibility and long coagulum formation times. Recently, a two-component hydrogel system called mediNiK® (Purenum GmbH, Germany) was developed. This biocompatible gel can be applied through an endoscope after stone fragmentation and large fragment retrieval to embed smaller fragments and dust, forming a removable conglomerate. MediNiK® has demonstrated effectiveness in embedding and removing stone residues and is already in clinical use in Europe, showing potential for optimizing stone removal. A multicenter study has assessed the safety and tolerability of mediNiK® in standard URS (Open, randomized, multicentre study to evaluate the safety, tolerability, and performance of mediNiK® compared to standard treatment in kidney stone removal - DRKS00030532). Results indicate the gel is safe and tolerable. However, further data from larger cohorts and comparisons with conventional URS are necessary before widespread adoption of mediNiK®.
Trial Details
NCT Number NCT06469736
Lead Sponsor Technical University of Munich
Conditions
(from sponsor)
Nephrolithiasis, Lithotripsy, Laser, Ureteroscopy
Related terms Nephrolithiasis
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov