Ureteral Obstruction Clinical Trial
Official title:
Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA™) in Ureteral Obstruction: Prospective, Multi-center, Open Label Study
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.
Prospective, Multi-center, open label, single arm Study
1. Treatment
- Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in
patents with malignant ureteral obstruction
2. 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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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