Ensayos clínicos

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 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.

4. 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. 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.

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 for
being unable to follow trial follow-up instructions or unable to reliably complete
patient questionnaires.

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

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

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/9/23. Questions regarding updates should be directed to the study team contact.