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

About

Brief Summary

A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
21 Years
Maximum Age
80 Years

Inclusion Criteria:

  • Subjects who are >21, <80 years of age; inclusive of males and females.
  • Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
  • 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.
  • 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:

  • Subjects with a history of an anatomical abnormality of the urinary tract.
  • Presence of ureteral fistula.
  • Presence of urothelial cancer, ureteral tumor, or renal tumor.
  • Presence of extrinsic compression of the ureter.
  • Presence of ureteral blockage or stricture.
  • Bladder outlet obstruction or neurogenic bladder.
  • Subjects with known/diagnosed overactive bladder (OAB).
  • Subjects with known/diagnosed urge urinary incontinence (UUI).
  • Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion.
  • Subjects with creatinine level of ˃2.5 mg/dl.
  • 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.
  • Impacted ureteral stones still in place and/or incomplete stone fragmentation.
  • Ureteral perforation.
  • Staghorn calculi.
  • Subjects with a solitary kidney.
  • History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed).
  • Contrast allergy that cannot be adequately pre-treated.
  • 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.
  • Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent.
  • Subject has a known significant concomitant illness with a life expectancy of <1 year.
  • Subject is known to be currently enrolled in another investigational trial.

Join this Trial

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Study Stats
Protocol No.
21-001086
Category
Urology
Contact
Karla Munoz
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04565795
For detailed technical eligibility, visit ClinicalTrials.gov.