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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Renal stent placed after uncomplicated uteroscopy
University of British Columbia
Vancouver, British Columbia, Canada
Safety
Composite of new-onset serious adverse event(s) including death, infection, the occurrence of surgery, re-hospitalization and or repeat hospitalization related to the device, or device related injury of the ureter.
Time frame: 90 days
Technical Success
Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology
Time frame: 90 days
Pain
Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire
Time frame: 90 days
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