NCT01788865

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ureteral Obstruction

Interventions

Type	Name	Description
DEVICE	cSEMS(Covered self-expandable dual-layered metal stent) implant

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-02-11
• Last updated: 2013-02-11

Locations

2 sites across 1 country: South Korea