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

Phase 4

• Conditions: Ureteral Obstruction
• Interventions: Device: cSEMS(Covered self-expandable dual-layered metal stent) implant

• Registration Number: NCT01788865
• Lead Sponsor: Samsung Medical Center

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Status Verified: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-07
• Last Update Submitted: 2013-02-07
• Study First Posted: 2013-02-11
• Last Update Posted: 2013-02-11
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary patency rate	12 months	Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ \< 20 min)

Secondary Outcome Measures

Name	Time	Method
Technical success rate	1week, 1 month	Rate of technical success(each Ureter) resolving the stenosis and passing the contrast medium from the kidney to urinary bladder
Final patency rate	12 months	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)
Adverse Event	1week, 1, 3, 6, 9, 12 months	Rate of total Adverse Events and Adverse Events relevant to Investigational Device
Predictive Risk Factors for Primary patency rate	12 months	Age, Sex, type of tumor(benign/malignant), length of stenosis, location of stenosis, UVJ cross, balloon catheterization, etc.
the primary patency rate among different location of distal stent	12 months	difference of the primary patency between the group of Distal stent located in urinary bladder and ureter
Ureteral stent symptom questionnaire(USSQ)	1, 3, 6, 9, 12 months	Comparative analysis of USSQ : before procedure and after procedure

Trial Locations

Locations (2)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of