NCT02032316

Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy

URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Adva-Tec · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Unilateral Ureteral Stone
• Renal Stone Fragments ≤ 2mm

Interventions

Type	Name	Description
DEVICE	Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent	Renal stent placed after uncomplicated uteroscopy

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-01-10
• Last updated: 2015-01-14

Locations

1 site across 1 country: Canada