RecruitingNAINTERVENTIONAL

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

This research is looking at better ways to remove kidney stones. When doctors use a tiny camera and laser (called ureterorenoscopy), sometimes small bits of stone are left behind, which can cause new stones to form. This study compares the standard procedure with a new approach using a special gel called mediNiK®. After breaking up the stones, the gel is used to gather these tiny remaining pieces, making them easier to remove. The goal is to clear out more of the stone fragments, hoping to reduce how often kidney stones come back and improve patients' health and well-being. Researchers want to see if adding this gel is safe and more effective than the usual method.

At a glance

Status

Recruiting

Phase

Sponsor

Technical University of Munich

Enrolment target

120

Start

01 Jul 2024

Estimated completion

30 Jul 2026

Nephrolithiasis Lithotripsy, Laser Ureteroscopy

What is this study about?

Kidney stones are a common problem affecting many people, including a growing number in the UK. When these stones cause trouble, doctors often use a procedure called ureterorenoscopy, where a thin tube with a camera and a laser is passed into the body to break up and remove the stones. While this method is very good, tiny fragments of stone can sometimes be left behind, which can lead to new stones forming later on. This can be painful, require more treatments, and impact people's daily lives.

Because of this, doctors and researchers are always looking for ways to improve stone removal and make sure as many fragments as possible are cleared out. This study focuses on a new idea using something called mediNiK®. It's a special gel that can be put into the body through the same tube after the laser has broken up the main stone. The gel works by surrounding and trapping the small stone fragments and dust, turning them into a bigger, more solid piece that's easier for the surgeon to remove.

The main goal of this study is to see if using this mediNiK® gel alongside the standard laser treatment helps remove more of the stone fragments compared to just using the laser on its own. They want to make sure it's safe and helps prevent new stones from forming. By clearing out more of the stone, the hope is to reduce the chances of you needing more treatments in the future and to improve your overall health and quality of life.

Key takeaways

This study compares standard kidney stone removal with a new gel.
The gel aims to clear tiny stone pieces left behind after laser treatment.
More complete removal could reduce the chance of new stones forming.
It could mean fewer future treatments and better quality of life.
Participation involves kidney stone procedure and follow-up checks.
Safety of the gel has been assessed, but more data is needed.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with kidney stones. Specifically, their kidney stone needs to be bigger than 10mm (about 1cm) when measured on a recent CT scan. You must also be able to understand and sign a consent form, showing you understand what taking part involves. If you are a woman who could have children, you will need to have a negative pregnancy test at the start of the study.

There are several reasons why someone might not be able to join. For example, if you've already taken part in another kidney stone study recently, or if you have certain other serious health issues like some types of cancer, severe kidney problems, or untreated infections. People with only one kidney or certain unusual kidney shapes, or those with blockages in the tubes leading from the kidney, also won't be able to join. Additionally, if you are pregnant or breastfeeding, you cannot participate. The medical team will check all these points carefully to make sure the study is safe for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a kidney stone larger than 10mm (1cm) according to a recent scan?
Are you able to speak and understand German?
Are you NOT pregnant or breastfeeding?
Have you NOT had another kidney stone study in the last 6 months?
Do you NOT have severe kidney disease or certain other serious health problems?

Answer every question to see your result.

What does participation involve?

The detailed participation plan is not fully described in the provided text. However, it would involve undergoing a procedure to remove kidney stones, likely at a hospital. You would be assigned to either receive the standard kidney stone removal or the standard method plus the new mediNiK® gel. There would be appointments before the procedure for checks, and follow-up appointments afterwards to see how you are recovering and if the stone removal was successful. The total duration of participation would cover these initial assessments, the procedure itself, and ongoing check-ups for a period afterwards to monitor for any remaining stone fragments or new stone formation.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of a more complete kidney stone removal, which might reduce the chance of needing further treatments in the future and improve your quality of life. However, as with any medical procedure, there are potential risks associated with both the standard kidney stone removal and the new gel, such as infection, bleeding, or other complications. The gel has been tested and shown to be safe and well-tolerated in previous studies, but researchers still need more information. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

University Hospital rechts der Isar
Verified postcode
Munich, Germany· Recruiting

Common questions

What are kidney stones?

Kidney stones are hard clumps of minerals and salts that can form inside your kidneys. They can be very painful and cause problems when they try to pass through your urinary system.

What is ureterorenoscopy?

It's a common procedure where a thin, flexible tube with a tiny camera and light is passed into your body to find and break up kidney stones with a laser.

What is mediNiK® gel?

MediNiK® is a special gel designed to be used during kidney stone removal. After the laser breaks up stones, the gel helps collect and remove tiny leftover pieces.

Why is it important to remove all stone fragments?

Even small pieces left behind can grow into new stones, causing more pain and requiring further treatments. Complete removal helps prevent stones from returning.

How long will the study last?

The information doesn't specify the exact duration, but it would involve checks before, during the procedure, and follow-up appointments afterwards to monitor your recovery and stone recurrence.

How to find out more

Thomas Amiel, doctor

thomas.amiel@tum.de 8941409678 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.