Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy (URIPRENE)
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|ClinicalTrials.gov Identifier: NCT02032316|
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Ureteral Stone Renal Stone Fragments ≤ 2mm||Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032316
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Ben Chew, MD||University of British Columbia|