/ Not yet recruitingNot Applicable Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent in Patients with Nephrolithiasis: a Multicentric, Randomized, Controlled Study
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.
/ CompletedNot Applicable HydrustomaC3 - Randomized Clinical Trial to Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care.
The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.
100 Clinical Results associated with Hydrumedical (Hydrustent SA)
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100 Deals associated with Hydrumedical (Hydrustent SA)
100 Translational Medicine associated with Hydrumedical (Hydrustent SA)