NCT04565795 Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
| NCT ID | NCT04565795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Adva-Tec |
| Condition | Ureteral Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 87 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2026-06 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
Eligibility Criteria
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