Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Adva-Tec
- Study ID
- NCT04565795
- Status
- Recruiting
Conditions
- Ureteral Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Uriprene® Degradable Temporary Ureteral Stent — DEVICEAssess 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 Details
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
Key Dates
- Start date
- Jul 1, 2022
- Status verified
- Sep 2025
- Primary completion
- Jun 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 87 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Placement of ureteral stent post ureteroscopySubjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS)
Primary Outcome Measure
Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours [ Time Frame: 48 hours ]
Central Contacts
- Jennifer Cartledge, MS(864) 506-0097
- Roberta Hines, BS(425) 766-0308
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | |
| University of California Los Angeles | Los Angeles | California | 90404 | |
| University of Florida | Gainesville | Florida | 32610 | |
| The Ohio State University | Columbus | Ohio | 43210 |