Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent
NCT: NCT06719089 · RECRUITING
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.
Frequently Asked Questions
What is 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 is a clinical trial registered under NCT06719089. Current status: RECRUITING.
What is the status of NCT06719089?
The current status of NCT06719089 (Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent) is: RECRUITING.
When did Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent start?
Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent started on 2025-09-09.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.