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

NCT06469736 | Recruiting

• 1 other identifier: 2023-395-S-KK
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Nephrolithiasis; Lithotripsy, Laser; Ureteroscopy

Keywords

Hydrogel; MediNiK; Hydrogel methode; Stone Free Rate; Zero Residual Fragments; URS; Dusting; Stone free; Thulium; Kidneystones

Outcome Measures

Primary Outcomes (1)

• Stone free Rate after URS

  To answer the primary research question, a comparison of the SFR between the two surgical procedures is planned using the chi-square test. In order to be able to show a statistically significant difference with regard to the surgical procedures according to the current data situation (75 % vs. 95 %), a sample size of 120 was defined with a power of 80 % and a significance level of 0.025 (the significance correction is made due to the definition of two co-primary endpoints in relation to the definition of freedom from stones).

  From enrollment to postoperative follow-up at 2 months.

Secondary Outcomes (7)

• Surgery Duration

  During the procedure

• Laser duration

  during the procedure

• Basketing duration

  during the procedure

• Complication

  after the procedure up to 1 month

• Subjective assessment of the operation by the surgeon

  During the procedure

Study Arms (2)

Standard of Care Ureterorenoscopy

SHAM COMPARATOR

Arm A) Standard procedure ( URS) for the removal of kidney stones using URS

Procedure: Standard of Care Ureterorenoscopy

Standard of Care Ureterorenoscopy with MediNik

ACTIVE COMPARATOR

Arm B) Standard procedure (URS) for the removal of kidney stones using URS in combination with the mediNiK®

Procedure: Standard of Care Ureterorenoscopy with MediNiK

Interventions

Standard of Care Ureterorenoscopy PROCEDURE

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.

Standard of Care Ureterorenoscopy

Standard of Care Ureterorenoscopy with MediNiK PROCEDURE

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.

Standard of Care Ureterorenoscopy with MediNik

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participation in another clinical trial for kidney stone removal in the last 6 months
• Subjects with gastrointestinal cancer who have not been in remission for at least 2 years
• Subjects with a single kidney, horseshoe kidney or other anatomical abnormalities that may increase the risk of surgery for the subject
• Subjects with untreated ureteral stenosis or renal stenosis and narrow ureteropelvic junction/ureterovesical junction
• Subjects with known impaired renal function from stage IV or known dialysis
• Subjects with chronic hydronephrosis not associated with nephrolithiasis
• Subjects with the following known or suspected diseases: Coagulation disorders, untreated urinary tract infections, renal disease sepsis and marked prostatic hyperplasia
• Subjects with any other disease or condition that, in the opinion of the investigator, could interfere with the purpose of the study (e.g. bleeding that restricts vision in the kidney, problems in the renal tubular system)
• Breastfeeding or pregnant women
• Subjects who may be part of a vulnerable group (e.g. prisoners or developmentally delayed adults)

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

University Hospital rechts der Isar

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Michael Straub, Doctor

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Amiel, doctor

CONTACT

8941409678; thomas.amiel@tum.de

Michael Straub, Doctor

CONTACT

8941402521

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: July 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)