Actively Recruiting
Standard Ureterorenoscopy With Lithotripsy Compared to Ureterorenoscopy With Lithotripsy plus MediNiK Hydrogel for Kidney Stone Removal: An Open, Randomized Study
Led by Technical University of Munich · Updated on 2025-09-09
120
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Kidney stones, known as urolithiasis, have become more common worldwide, affecting about 15% of people. Diagnoses and surgical removals have increased notably in countries like Germany, France, and England over recent years. Ureterorenoscopy (URS), a procedure using laser technology to break up stones, is often preferred but can leave small fragments behind, which may cause new stones to form. Reducing these residual fragments is important to lower recurrence rates and improve patient quality of life while managing healthcare costs. This study compares two treatment approaches for kidney stone removal: the standard URS with lithotripsy alone and URS combined with a new two-component hydrogel called mediNiK®. The hydrogel is applied after stone fragmentation to embed and capture smaller stone fragments, enabling easier removal. Both procedures involve positioning the patient, sterile preparations, cystoscopy, guidewire placement, and laser fragmentation of stones, followed by stent and catheter placement. The study aims to assess how well mediNiK® improves stone clearance compared to standard care. Participants will undergo treatment and be followed up for several months to monitor stone clearance rates, surgery duration, complications, and costs. Assessments include postoperative imaging at two months, tracking stone-related events up to three months, and cost analysis up to twelve months. Researchers will also gather feedback from surgeons about the procedures. The study's results are intended to provide valuable information for improving kidney stone treatment practices and outcomes.
CONDITIONS
Brief Title
Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with kidney stones confirmed by a CT scan within the last 6 months
- Kidney stones larger than 10 mm in the longest measurement
- Able to read, write, and speak German
- Women of childbearing age must have a negative pregnancy test before starting
- Signed informed consent given after understanding the study details
You will not qualify if you...
- Participated in another kidney stone removal clinical trial within the last 6 months
- Have gastrointestinal cancer not in remission for at least 2 years
- Have a single kidney, horseshoe kidney, or other kidney abnormalities increasing surgical risk
- Untreated narrowing of the ureter or kidney blood vessels
- Known severe kidney impairment (stage IV) or on dialysis
- Chronic kidney swelling not caused by stones
- Known or suspected bleeding disorders, untreated urinary tract infections, kidney sepsis, or severe prostate enlargement
- Any condition that could affect study goals, such as bleeding that limits kidney visibility
- Pregnant or breastfeeding women
- Part of vulnerable groups like prisoners or developmentally disabled adults
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo ureterorenoscopy with lithotripsy to remove kidney stones, either with or without the addition of mediNiK hydrogel to embed and extract residual stone fragments.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored postoperatively to assess stone clearance, complications, and stone-related events.
Multiple visits including a 2-month postoperative follow-up and additional visits up to 12 months
Trial Site Locations
Total: 1 location
1
University Hospital rechts der Isar
Munich, Bavaria, Germany, 81675
Actively Recruiting
Research Team
T
Thomas Amiel, doctor
M
Michael Straub, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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