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

URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec 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.

Study Overview

• Status: Recruiting
• Conditions: Ureteral Diseases
• Intervention / Treatment: Device: Uriprene® Degradable Temporary Ureteral Stent

Detailed Description

A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent. The study is intended to assess the safety and efficacy of the Uriprene® Stent by assessing adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.

• Study Type: Interventional
• Enrollment (Estimated): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Cartledge, MS; Phone Number: (864) 506-0097; Email: jcartledge@adva-tec.com
• Study Contact Backup: Name: Roberta Hines, BS; Phone Number: (425) 766-0308; Email: rhines@nwcrg.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
      • Contact: Mitch Humphreys, MD; Phone Number: 480-342-2793; Email: humphreys.mitchell@mayo.edu
  • California
    • Los Angeles, California, United States, 90404
      • Recruiting
      • University of California Los Angeles
      • Contact: Matthew Dunn, MD; Phone Number: 424-259-7909; Email: MDDunn@mednet.ucla.edu
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Contact: Vincent Bird, MD; Phone Number: 352-294-5120; Email: vincent.bird@urology.ufl.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Bodo Knudsen, MD; Phone Number: 614-293-8155; Email: bodo.knudsen@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placement of ureteral stent post ureteroscopy; Subjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS)	Device: Uriprene® Degradable Temporary Ureteral Stent; Assess adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours	Study Success defined as adequate short-term urine drainage, defined as the presence of the stent in the ureter and the lack of surgical or invasive intervention to treat symptoms in the stented ureter during the first 48 hours following placement.	48 hours
Primary Safety Endpoint defined as assessment of adverse events through 90 days	Assessment of Adverse Events through the 90-day follow-up period (incidence, relationship to device and severity) compared to the historical control degradable ureteral stent and plastic ureteral stents	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Clinical Success	Adequate urine drainage with no intervention and no definitely device-related serious adverse events (SAEs) throughout the 90-day follow-up period.	90 days
Technical success of the device	Complete degradation/elimination of the stent from the urinary system within 90 days as measured by radiological assessment.	90 days
Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.	Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.	90 days

Collaborators and Investigators

• Sponsor: Adva-Tec
• Collaborators: Northwest Clinical Research Group
• Investigators: Principal Investigator: Mitchell Humphreys, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ureteral stent
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Ureteral Diseases
• Other Study ID Numbers: CLN 0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes