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

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 NOTIN THE RENAL PELVIS OR URETER and who have had uncomplicated ureteroscopy (UURS) canbe included. If, during the course of treatment of the target ureter with theUriprene stent the patient's asymptomatic stone becomes symptomatic and requirestreatment, the patient can only be managed with standard of care treatment includingthe 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 30mm long ureteral stent, as judged by the Investigator.

5. Subjects with the ability to understand the requirements of the study, who haveprovided written informed consent, and are willing to undergo all follow-upassessments 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 ofstent insertion.

10. Subjects with creatinine level of ˃2.5 mg/dl.

11. Pregnant or lactating women, or women of childbearing potential who do not employ areliable method of contraception as judged by the Investigator, and/or are notwilling to use reliable contraception for the duration of study participation.

12. Impacted ureteral stones still in place and/or incomplete stone fragmentation.

13. Ureteral perforation.

14. Staghorn calculi.

15. Subjects with a solitary kidney.

16. History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed).

17. Contrast allergy that cannot be adequately pre-treated.

18. Subject has known severe psychiatric disorder, substance abuse, or other reason forbeing unable to follow trial follow-up instructions or unable to reliably completepatient questionnaires.

19. Any condition, in the opinion of the investigator, that would deem a subject asineligible for treatment with the Uriprene® Stent.

20. Subject has a known significant concomitant illness with a life expectancy of <1year.

21. Subject is known to be currently enrolled in another investigational trial.