Evaluation of the Safety and Performance of the Hydrustent4 Biodegradable Hydrogel Ureteral Stent in Patients With Nephrolithiasis A Multicentric, Randomized, Controlled Study

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the Hydrustent4 biodegradable hydrogel ureteral stent in adults with urinary lithiasis who have undergone surgery to remove ureteral or renal stones. The study will compare Hydrustent4 to a standard ureteral stent device to determine if it is at least as safe and effective in maintaining urine flow through the ureter after surgery. The trial includes both a pilot phase to explore initial safety and efficacy and a pivotal phase to confirm clinical performance. Participants will receive either the Hydrustent4 stent or a comparator ureteral stent after stone removal surgery. The Hydrustent4 device is designed to degrade naturally in the body, potentially avoiding the need for a second surgery to remove the stent, while the comparator is a conventional polyurethane double loop stent. The study will monitor the durability of the device for at least 24 hours and assess whether the device reduces urinary symptoms and prevents additional surgical procedures. During the 3-month follow-up period, participants will attend regular visits for assessments including questionnaires, imaging exams, and blood and urine tests to monitor recovery and device performance. Researchers will closely track safety through adverse events and device issues, evaluate urine drainage after stent placement, and assess symptoms related to the stents. The study will measure both technical success and tolerability of the devices throughout the treatment and follow-up phases.

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