Renal Stone Fragments = 2mm Clinical Trial
Official title:
URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy
A prospective, single-center, single-arm, trial to demonstrate safety and device performance of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man clinical study in a small human population.
Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing
the time to complete degradation or the passage of stent fragments from the bladder by
radiological assessment.
Subject Population: Patients with clinical symptoms consistent with unilateral ureteral or
renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (UURS).
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment