RecruitingNot ApplicableNCT06719089

Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent

Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent in Patients With Nephrolithiasis: A Multicentric, Randomized, Controlled Study


Sponsor

Hydrumedical

Enrollment

134 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical investigation is to evaluate whether the Hydrustent® medical device is safe and if maintain the urinary flow inside the ureter in adults. The main questions it aim to answer are: * Does Hydrustent® maintain urinary patency post-surgery in adults? * What medical issues do participants experience while using Hydrustent®? Researchers will compare the Hydrustent® medical device to a comparator (a standard medical device used in clinical practice) to determine whether Hydrustent® is at least non-inferior in terms of safety and efficacy. Other questions that the study will answer are: * Does Hydrustent® exhibit a durability of at least 24 hours? * Does Hydrustent® prevents the need of the surgical procedure to remove the ureteral stent? * Does Hydrustent® reduce urinary symptoms associated with a ureteral stent? Participants will: * Have either the Hydrustent® or a comparator device inserted following the removal of ureteral or renal stones via endourological techniques. * Be monitored for 3 months post-surgery through regular follow-up visits. * Complete questionnaires and undergo imaging exams, as well as blood and urine analyses to assess recovery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Biodegradable double loop ureteral stent and a medical device called PolyUrethane Double Loop Ureteral Stent for people with urinary lithiasis. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBiodegradable double loop ureteral stent

This ureteral stent is based on natural polymers and degrades inside the human body without causing obstruction, avoiding the need of a second surgery for stent removal and minimizing complications related to encrustation and bacterial infections.

DEVICEPolyUrethane Double Loop Ureteral Stent

This ureteral stent is a double J made of 100% polyurethan, heat-sensitive and radiopaque for excellent patient tolerance and high incrustation resistance.


Locations(4)

Unidade Local de Saúde da Região de Aveiro (ULSRA), E.P.E.

Aveiro, Aveiro District, Portugal

Unidade Local de Unidade Local de Saúde do Alto Ave (ULSAAVE), E.P.E

Guimarães, Braga District, Portugal

Hospital CUF Tejo

Lisbon, Portugal

Unidade Local de Saúde do Alto Minho (ULSAM)

Viana do Castelo, Portugal

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NCT06719089


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