Comparing two methods for kidney stone removal
Standard of Care Ureterorenoscopy With Lithotripsy Versus in Combination With the Hydrogel Method for Kidney Stone Removal: An Open, Randomized, Monocentric Study
NA · Technical University of Munich · NCT06469736
This study is testing whether using a special gel along with a common kidney stone removal method can help people get rid of stones more effectively than just using the method alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich (other) |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT06469736 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of ureterorenoscopy with lithotripsy alone versus a combination of ureterorenoscopy with a hydrogel treatment for the removal of kidney stones. The study aims to determine which method results in a higher stone-free rate and reduces the likelihood of residual fragments that can lead to recurrence. Participants will undergo a preoperative CT scan to confirm the presence of nephrolithiasis, and those with stones larger than 10mm will be included. The trial will assess outcomes related to stone clearance and patient quality of life post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with nephrolithiasis and kidney stones larger than 10mm.
Not a fit: Patients with anatomical abnormalities affecting kidney surgery or those who have participated in other kidney stone trials recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney stone removal techniques, reducing recurrence rates and enhancing patient quality of life.
How similar studies have performed: While there have been studies on ureterorenoscopy and lithotripsy, the specific combination with hydrogel is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where this trial is running
Munich, Bavaria
- University Hospital rechts der Isar — Munich, Bavaria, Germany (RECRUITING)
Study contacts
- Principal investigator: Michael Straub, Doctor — Technical University of Munich
- Study coordinator: Thomas Amiel, doctor
- Email: thomas.amiel@tum.de
- Phone: 8941409678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nephrolithiasis, Lithotripsy, Laser, Ureteroscopy, Hydrogel, MediNiK, Hydrogel methode, Stone Free Rate, Zero Residual Fragments