Standard of Care Ureterorenoscopy With Lithotripsy Versus in Combination With the Hydrogel Method for Kidney Stone Removal: An Open, Randomized, Monocentric Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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®.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female subjects aged ≥ 18 years

• Evidence of nephrolithiasis on presentation of a preoperative computer tomography (CT) scan not older than 6 months

• Minimum size of the kidney stones defined as \>10mm in the longest axis in the preoperative CT.

• Ability to read, write and speak German

• Women of childbearing age must have a negative serum pregnancy test at the start of the study.

• Submission of a personally signed and dated informed consent form stating that the subject has been informed of all relevant aspects of the study prior to any trial-related activity and that all information has been understood

Locations
Other Locations
Germany
University Hospital rechts der Isar
RECRUITING
Munich
Contact Information
Primary
Thomas Amiel, doctor
thomas.amiel@tum.de
8941409678
Backup
Michael Straub, Doctor
8941402521
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 120
Treatments
Sham_comparator: Standard of Care Ureterorenoscopy
Arm A) Standard procedure ( URS) for the removal of kidney stones using URS
Active_comparator: Standard of Care Ureterorenoscopy with MediNik
Arm B) Standard procedure (URS) for the removal of kidney stones using URS in combination with the mediNiK®
Sponsors
Leads: Technical University of Munich

This content was sourced from clinicaltrials.gov