Actively Recruiting
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
Led by Adva-Tec · Updated on 2025-10-01
87
Participants Needed
4
Research Sites
217 weeks
Total Duration
On this page
Sponsors
A
Adva-Tec
Lead Sponsor
N
Northwest Clinical Research Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
CONDITIONS
Official Title
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 80 years, including males and females
- Have unilateral ureteral or renal stones and undergone successful, uncomplicated ureteroscopy
- May have asymptomatic contralateral renal stones smaller than 4 mm not located in the renal pelvis or ureter, with uncomplicated ureteroscopy
- Body size suitable to accommodate a 20 to 30 mm ureteral stent as judged by the investigator
- Ability to understand study requirements, provide written informed consent, and comply with follow-up assessments
You will not qualify if you...
- History of anatomical abnormalities of the urinary tract
- Presence of ureteral fistula
- Presence of urothelial cancer, ureteral tumor, or renal tumor
- Extrinsic compression of the ureter
- Ureteral blockage or stricture
- Bladder outlet obstruction or neurogenic bladder
- Diagnosis of overactive bladder or urge urinary incontinence
- Active upper or lower urinary tract infection at stent insertion
- Creatinine level greater than 2.5 mg/dl
- Pregnant or lactating women or women not using reliable contraception
- Impacted ureteral stones or incomplete stone fragmentation
- Ureteral perforation
- Staghorn calculi
- Solitary kidney
- History of bleeding disorders or current use of blood thinners like warfarin
- Contrast allergy that cannot be pre-treated
- Severe psychiatric disorder or substance abuse affecting follow-up
- Any condition making subject ineligible for Uriprene4 stent treatment
- Life expectancy less than 1 year due to significant illness
- Currently enrolled in another investigational trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90404
Actively Recruiting
3
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
4
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
J
Jennifer Cartledge, MS
CONTACT
R
Roberta Hines, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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