Summary

Eligibility
for people ages 21-80 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Ureteral Diseases, ureteral stent, Uriprene® Degradable Temporary Ureteral Stent, Placement of ureteral stent post ureteroscopy

Eligibility

You can join if…

Open to people ages 21-80

  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.

You CAN'T join if...

  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.

Locations

  • University of California San Diego accepting new patients
    San Diego California 92103 United States
  • University of California Los Angeles accepting new patients
    Los Angeles California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Adva-Tec
ID
NCT04565795
Study Type
Interventional
Participants
Expecting 87 study participants
Last Updated