Open Actively Recruiting
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
- 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 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.
- 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.
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