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

Launched by TECHNICAL UNIVERSITY OF MUNICH · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two methods for removing kidney stones: one that uses a laser to break the stones apart (ureterorenoscopy with lithotripsy) and another that combines this method with a special gel called mediNiK®. The gel is designed to help capture and remove smaller stone fragments that are often left behind after treatment, which can reduce the chances of the stones coming back. The study aims to find out how safe and effective this gel is compared to the standard treatment.

To participate in this trial, you need to be at least 18 years old and have kidney stones that are larger than 10mm, as shown by a recent CT scan. You also need to be able to read, write, and speak German, and if you're a woman of childbearing age, you'll need to have a negative pregnancy test. Throughout the trial, participants will receive care and monitoring related to their kidney stones. The researchers are looking for a diverse group of people to help ensure the results are applicable to many patients.

Gender

ALL

Eligibility 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)