A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent. The study is intended to assess the safety and efficacy of the Uriprene® Stent by assessing adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Assess adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.
Mayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGUniversity of California Los Angeles
Los Angeles, California, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGPrimary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours
Study Success defined as adequate short-term urine drainage, defined as the presence of the stent in the ureter and the lack of surgical or invasive intervention to treat symptoms in the stented ureter during the first 48 hours following placement.
Time frame: 48 hours
Primary Safety Endpoint defined as assessment of adverse events through 90 days
Assessment of Adverse Events through the 90-day follow-up period (incidence, relationship to device and severity) compared to the historical control degradable ureteral stent and plastic ureteral stents
Time frame: 90 days
Overall Clinical Success
Adequate urine drainage with no intervention and no definitely device-related serious adverse events (SAEs) throughout the 90-day follow-up period.
Time frame: 90 days
Technical success of the device
Complete degradation/elimination of the stent from the urinary system within 90 days as measured by radiological assessment.
Time frame: 90 days
Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.
Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Ohio State University
Columbus, Ohio, United States
RECRUITING