Comparing two methods for kidney stone removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Compare two suction ureteroscope devices for kidney stones (FANS vs CVAC)

  This study tests whether two new suction-enabled ureteroscopes (FANS and CVAC) lead to better stone clearance for adults with small to medium kidney stones compared to each other.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.