Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy (URIPRENE)
|Unilateral Ureteral Stone Renal Stone Fragments ≤ 2mm||Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy|
- Safety [ Time Frame: 90 days ]Composite of new-onset serious adverse event(s) including death, infection, the occurrence of surgery, re-hospitalization and or repeat hospitalization related to the device, or device related injury of the ureter.
- Technical Success [ Time Frame: 90 days ]Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology
- Pain [ Time Frame: 90 days ]Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire
|Study Start Date:||March 2014|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Placement of ureteral stent following post-ureteroscopy
Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent
Renal stent placed after uncomplicated uteroscopy
Other Name: Renal ureteral stent
Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing the time to complete degradation or the passage of stent fragments from the bladder by radiological assessment.
Subject Population: Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (UURS).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02032316
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Ben Chew, MD||University of British Columbia|