Sticky gel mops up kidney stone dust after laser blast

NCT ID NCT06469736

Disease control Sponsor: Technical University of Munich Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a special hydrogel, squirted into the kidney after laser stone removal, can trap tiny leftover fragments and be pulled out whole. About 120 adults with kidney stones larger than 10 mm will be randomly assigned to standard surgery alone or surgery plus the gel. The goal is to see if the gel helps leave the kidney completely stone-free, which could lower the chance of stones coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: mediNiK® hydrogel
What this could lead to: If successful, this could become a standard addition to kidney stone surgery, helping to remove tiny fragments that often cause new stones.
What could go wrong: This is a single-center trial with 120 people, so results may not apply broadly. The hydrogel is new and long-term safety data are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lithotripsy, laser Nephrolithiasis Ureteroscopy

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Sticky gel mops up kidney stone dust after laser blast

What the study statuses mean