NCT04565795

Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy

URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Adva-Tec · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.

Detailed description

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.

Conditions

• Ureteral Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-01
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2020-09-25
• Last updated: 2025-10-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study