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

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.

This description comes directly from the study's public registry record.

Ferreira (Sponsor)  ·  +351 253 573 460  ·  clinicalstudies@hydrumedical.pt

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