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

Recruiting now · Not applicable

Conditions studied: Ureteral Diseases

In brief

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

Key facts

Study ID

NCT04565795

Run by

Adva-Tec

People needed

87

Starts

2022-07-01

Expected to finish

2026-09-01

Last updated by the study team

2025-10-01

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are >21, <80 years of age; inclusive of males and females.
• Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
• 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.
• 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.
• 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.

You may not qualify if…

• Subjects with a history of an anatomical abnormality of the urinary tract.
• Presence of ureteral fistula.
• Presence of urothelial cancer, ureteral tumor, or renal tumor.
• Presence of extrinsic compression of the ureter.
• Presence of ureteral blockage or stricture.
• Bladder outlet obstruction or neurogenic bladder.
• Subjects with known/diagnosed overactive bladder (OAB).
• Subjects with known/diagnosed urge urinary incontinence (UUI).
• Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion.
• Subjects with creatinine level of ˃2.5 mg/dl.
• Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
• Impacted ureteral stones still in place and/or incomplete stone fragmentation.
• Ureteral perforation.
• Staghorn calculi.
• Subjects with a solitary kidney.
• History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed).
• Contrast allergy that cannot be adequately pre-treated.
• Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions or unable to reliably complete patient questionnaires.
• Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent.
• Subject has a known significant concomitant illness with a life expectancy of <1 year.
• Subject is known to be currently enrolled in another investigational trial.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)
• University of California Los Angeles — Los Angeles, California, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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