Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA) in Ureteral Obstruction

Study Overview
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Brief Summary
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The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.

Detailed Description
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Prospective, Multi-center, open label, single arm Study Treatment - Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction Follow up Assessments including X-ray(KUB), are done 3, 6, 12, 18 and 24 months after the procedure. Diuretic RI scan (DTPA, MAG-3) 3, 6, 12 months after the procedure Imaging such as IVP(Intravenous Pyelogram), ultrasonogram, CT(Computed Tomogram) are performed at 6 and 12 months.

Official Title
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Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA™) in Ureteral Obstruction: Prospective, Multi-center, Open Label Study

Conditions
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Ureteral Obstruction

Intervention / Treatment
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* Device: cSEMS(Covered self-expandable dual-layered metal stent) implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20 80 years One out of following cases below apply to Patients who have malignant ureteral obstruction or have benign ureteral obstruction without improvement after previous treatment Patients who doesn't want to have regular replacement of plastic stent Patients who has no improvement of obstruction after plastic stent implant Patients who want other Urinary diversion because of stimulatory sign or pain due to plastic stent Patients with no previous ureteral metal stenting procedure experience. Patients with more than 6 months of life expectancy Patients understanding the objective of the study and who are willing to sign a consent Exclusion Criteria: Patients with Urothelial Carcinoma Patients with bladder invasion of malignant tumor Patients with bladder dysfunction or obstruction of lower urinary tract one or more times Recurrent Urinary stone in the last 3 years 2 or more times upper urinary tract infection without upper urinary tract obstruction Karnofsky scores < 60 Patients with Bacteriuria Inadequate Patient to participate in the study as judged by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: cSEMS<br>Patients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant | Device: cSEMS(Covered self-expandable dual-layered metal stent) implant<br> <br> * Other names: UVENTA™ Ureteral Stent, Taewoong medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate | Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Rate of technical success(each Ureter) resolving the stenosis and passing the contrast medium from the kidney to urinary bladder | 1week, 1 month | 
| Final patency rate | Rate of Ureter units maintaining patency without interventions aside from re-stenting(investigational device) after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min) | 12 months | 
| Adverse Event | Rate of total Adverse Events and Adverse Events relevant to Investigational Device | 1week, 1, 3, 6, 9, 12 months | 
| Predictive Risk Factors for Primary patency rate | Age, Sex, type of tumor(benign/malignant), length of stenosis, location of stenosis, UVJ cross, balloon catheterization, etc. | 12 months | 
| the primary patency rate among different location of distal stent | difference of the primary patency between the group of Distal stent located in urinary bladder and ureter | 12 months | 
| Ureteral stent symptom questionnaire(USSQ) | Comparative analysis of USSQ : before procedure and after procedure | 1, 3, 6, 9, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covered Metal stent, ureteral obstruction