NCT06719089

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Hydrumedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multicentric, randomized, controlled clinical study comprising both phases of the pre-market device clinical development stage: pilot and pivotal. The first exploratory phase of the study (16 participants) will assess the safety of Hydrustent® for the first time in humans, while providing preliminary results on its efficacy. Following this, the second phase is confirmatory (118 participants), allowing the collection of the information necessary to evaluate the clinical performance and safety of Hydrustent®.

Conditions

• Urinary Lithiasis

Interventions

Type	Name	Description
DEVICE	Biodegradable 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.
DEVICE	PolyUrethane 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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-05
• Last updated: 2025-06-04

Locations

4 sites across 1 country: Portugal