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Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy | Clinical Trials | Clareo Health

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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

NCT04565795•Adva-Tec

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects who are \>21, \<80 years of age; inclusive of males and females.
•2. Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
•3. Subjects with asymptomatic, contralateral renal stones in sizes \<4mm WHICH ARE NOT IN THE RENAL PELVIS OR URETER and who have had uncomplicated ureteroscopy (UURS) can be included. If, during the course of treatment of the target ureter with the Uriprene stent the patient's asymptomatic stone becomes symptomatic and requires treatment, the patient can only be managed with standard of care treatment including the use of an approved ureteral stent, if necessary.
•4. Subjects with a height and body size able to accommodate a 20, 22, 24, 26, 28, or 30 mm long ureteral stent, as judged by the Investigator.
•5. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and are willing to undergo all follow-up assessments according to the specified schedule.

Exclusion Criteria

•1. Subjects with a history of an anatomical abnormality of the urinary tract.
•2. Presence of ureteral fistula.
•3. Presence of urothelial cancer, ureteral tumor, or renal tumor.
•4. Presence of extrinsic compression of the ureter.
•5. Presence of ureteral blockage or stricture.
•6. Bladder outlet obstruction or neurogenic bladder.
•7. Subjects with known/diagnosed overactive bladder (OAB).
•8. Subjects with known/diagnosed urge urinary incontinence (UUI).
•9. Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion.
•10. Subjects with creatinine level of ˃2.5 mg/dl.
+11 more criteria

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

Key Dates

Start Date

July 1, 2022

Primary Completion Date

June 1, 2026

Completion Date

September 1, 2026

Last Updated

October 1, 2025

Enrollment

ESTIMATED participants

Conditions

Ureteral Diseases

Interventions

Uriprene® Degradable Temporary Ureteral Stent

DEVICE

Contacts

Jennifer Cartledge, MS

CONTACT

(864) 506-0097 jcartledge@adva-tec.com

Roberta Hines, BS

CONTACT

(425) 766-0308 rhines@nwcrg.com

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Ureteral Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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