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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
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A prospective, single-center, single-arm, trial to demonstrate safety and device performance of the ADVA-Tec Uripreneâ„¢ Degradable Temporary Ureteral Stent. This is a first-in-man clinical study in a small human population.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Placement of ureteral stent following post-ureteroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-Ureteroscopy ADVA-Tec Uripreneâ„¢ Degradable Temporary Ureteral Stent | Device | Renal stent placed after uncomplicated uteroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology | 90 days |
| Pain | Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Chew, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 90 days |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |