Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy

Study Overview
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Brief Summary
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A prospective, single-center, single-arm, trial to demonstrate safety and device performance of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man clinical study in a small human population.

Detailed Description
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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).

Official Title
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URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy

Conditions
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Renal Stone Fragments ≤ 2mm, Unilateral Ureteral Stone

Intervention / Treatment
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* Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are > 18, < 80 years of age; inclusive of males and females. Patients with unilateral ureteral or renal stone fragments < 2mm, post-uncomplicated ureteroscopy (UURS). Patients 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. Patients with the ability to understand the requirements of the study, who have provided written informed consent, and who have agreed to return for the required follow-up assessments. Exclusion Criteria: Patients with a known contraindication for treatment with the Uriprene® Stent. Patients with a history of an anatomical abnormality of the urinary tract. Patients with a known upper or lower urinary tract infection at the time of stent insertion. Patients with known renal insufficiency or chronic impairment. Any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the Uriprene® Stent. Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator. Patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent). Presence of ureteral blockage or stricture After failed guide wire placement or failed ureteroscopic access Impacted ureteral stones still in place Patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy Patients with a solitary kidney Presence of ureteral fistula Presence of ureteral tumor Presence of extrinsic compression of the ureter Urinary tract infection Staghorn calculi

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Placement of ureteral stent following post-ureteroscopy | Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent<br>* Renal stent placed after uncomplicated uteroscopy<br>* Other names: Renal ureteral stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Stone, Ureteroscopy, Ureteral Stent, post-uncomplicated ureteroscopy, UURS