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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01788865
Study type Interventional
Source Samsung Medical Center
Contact Deok Hyun Han, M.D.
Phone 82-2-3410-6431
Email deokhyun.han@gmail.com
Status Recruiting
Phase Phase 4
Start date June 2012
Completion date June 2014

See also
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