Clinical Research Directory

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.

Stone Disease of the Urinary Tract in Children

The incidence of stone disease of the urinary tract in children is increasingly increasing with a remarkable economic impact for its management. This incidence is variable according to race, geographic region, socio-economic status and dietary habits. Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies depending on the region where those of a phosphatic nature are characterized by a higher incidence in Europe. The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic accuracy. The scanner is the reference tool but remains an irradiating examination. Risk factors for disease recurrence include primarily the presence of an underlying urinary metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to another. The understanding of lithogenesis, its evaluation as well as the therapeutic options is essential for adequate and adapted management in the pediatric population.