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

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

March 30, 2026

Study Completion Date

July 30, 2026

Conditions
NephrolithiasisLithotripsy, LaserUreteroscopy
Interventions
PROCEDURE

Standard of Care Ureterorenoscopy

The patient provides written informed consent and is positioned in the supine position. After disinfection, sterile draping, and single-shot antibiotic administration a rigid cystoscopy is performed. Intubation of the ostium with a hydrophilic guidewire and placed into the renal pelvis under fluoroscopic control. After a semirigid URS, a working sheath is placed up to the Kidney. A flexible URS with lithotripsy with a Thulium lase is then performed to dust the stones. The fragments are retrieved for analysis. Finally, a double-J or mono-J stent and a transurethral catheter are placed.

PROCEDURE

Standard of Care Ureterorenoscopy with MediNiK

The patient provides written informed consent and is positioned in the supine position. After disinfection, sterile draping, and single-shot antibiotic administration a rigid cystoscopy is performed. Intubation of the ostium with a hydrophilic guidewire and placed into the renal pelvis under fluoroscopic control. After a semirigid URS, a working sheath is placed up to the Kidney. A flexible URS with lithotripsy with a Thulium lase is then performed to dust the stones. The fragments are retrieved for analysis. Application of MediNiK to embbed the residual stones in the hydrogel and extract it with a basket. Finally, a double-J or mono-J stent and a transurethral catheter are placed.

Trial Locations (1)

81675

RECRUITING

University Hospital rechts der Isar, Munich

All Listed Sponsors
lead

Technical University of Munich

OTHER