Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
NCT04565795 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2025-10-01
Summary
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
Conditions
- Ureteral Diseases
Interventions
- DEVICE
-
Uriprene® Degradable Temporary Ureteral Stent
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.
Sponsors & Collaborators
-
Northwest Clinical Research Group
collaborator UNKNOWN -
Adva-Tec
lead INDUSTRY
Principal Investigators
-
Mitchell Humphreys, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2026-06-30
- Completion
- 2026-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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