Evaluating a new degradable ureteral stent for safety and performance

URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy

This study is testing a new type of temporary ureteral stent to see if it's safe and works well for people who need help with urine drainage.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: Adva-Tec (Industry-sponsored)
• Locations: 4 sites (Phoenix, Arizona and 3 other locations)
• Trial ID: NCT04565795 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, multi-center, non-randomized evaluation of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent. The study aims to assess the safety and efficacy of the stent by monitoring intervention-free drainage and the time it takes for the stent to degrade or pass through the urinary system. Participants will undergo follow-up assessments to evaluate the stent's performance and safety during and after its use.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 80 with unilateral ureteral or renal stones who have undergone uncomplicated ureteroscopy.

Not a fit: Patients with symptomatic contralateral renal stones or those who cannot accommodate the stent size may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective option for patients requiring ureteral stenting.

How similar studies have performed: Other studies have shown promise with similar degradable stent technologies, suggesting potential for success in this approach.

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 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.

Where this trial is running

Phoenix, Arizona and 3 other locations

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

Study contacts

• Principal investigator: Mitchell Humphreys, MD — Mayo Clinic
• Study coordinator: Jennifer Cartledge, MS

Conditions Ureteral Diseases; ureteral stent