Hydrustent® Safety and Performance

Official Title

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

Brief 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.