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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

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.

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Detailed Description

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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

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Ureteral Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cSEMS

Patients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant

Group Type EXPERIMENTAL

cSEMS(Covered self-expandable dual-layered metal stent) implant

Intervention Type DEVICE

Interventions

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cSEMS(Covered self-expandable dual-layered metal stent) implant

Intervention Type DEVICE

Other Intervention Names

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UVENTA™ Ureteral Stent, Taewoong medical

Eligibility Criteria

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Inclusion Criteria

1. Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20\~80 years
2. 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
3. Patients with no previous ureteral metal stenting procedure experience.
4. Patients with more than 6 months of life expectancy
5. Patients understanding the objective of the study and who are willing to sign a consent

Exclusion Criteria

1. Patients with Urothelial Carcinoma
2. Patients with bladder invasion of malignant tumor
3. Patients with bladder dysfunction or obstruction of lower urinary tract
4. one or more times Recurrent Urinary stone in the last 3 years
5. 2 or more times upper urinary tract infection without upper urinary tract obstruction
6. Karnofsky scores \< 60
7. Patients with Bacteriuria
8. Inadequate Patient to participate in the study as judged by the investigator

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No