RecruitingNot ApplicableNCT04565795

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


Sponsor

Adva-Tec

Enrollment

87 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests the Uriprene — a novel biodegradable (self-dissolving) ureteral stent — in patients who have just had uncomplicated ureteroscopy for kidney or ureteral stones. Standard ureteral stents are placed after stone removal to keep the ureter open while it heals, but these must be removed in a separate procedure. The Uriprene stent is designed to dissolve on its own, potentially eliminating the need for a removal procedure and reducing patient discomfort and healthcare burden. The study is for adults aged 21 to 80 who have just completed a successful, uncomplicated ureteroscopy on one side for a kidney or ureteral stone. Participants must be willing and able to attend all follow-up visits. You may be eligible if: - You are between 21 and 80 years old - You have just had a successful, uncomplicated ureteroscopy for a kidney or ureteral stone - You are otherwise healthy enough to participate and can attend all follow-up visits You may NOT be eligible if: - You have a known abnormality of the urinary tract, ureteral stricture, or blockage - You have a urothelial (bladder/ureteral) cancer or renal tumor - You have an active urinary tract infection - Your kidney function is significantly impaired (creatinine above 2.5 mg/dL) - You are pregnant or breastfeeding - You have a solitary kidney - You have a bleeding disorder or are on blood thinners (other than antiplatelet agents) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUriprene® 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.


Locations(4)

Mayo Clinic Arizona

Phoenix, Arizona, United States

University of California Los Angeles

Los Angeles, California, United States

University of Florida

Gainesville, Florida, United States

The Ohio State University

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT04565795


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