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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Ureteral Obstruction	Device: cSEMS(Covered self-expandable dual-layered metal stent) implant	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	92 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	June 2012
Estimated Primary Completion Date :	June 2014
Estimated Study Completion Date :	June 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: cSEMS; Patients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant	Device: cSEMS(Covered self-expandable dual-layered metal stent) implant; Other Name: UVENTA™ Ureteral Stent, Taewoong medical

Outcome Measures

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Primary Outcome Measures :

1. Primary patency rate [ Time Frame: 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 :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Contacts

Contact: Deok Hyun Han, M.D.	82-2-3410-6431	deokhyun.han@gmail.com

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of
Contact: Hyeong keoun Park, M.D. Ph.D, +82-2-3010-3737 hkpark@amc.seoul.kr
Principal Investigator: Hyeongkeun Park, M.D. Ph.D.
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of
Contact: Deokhyun Han, M.D. +82-10-9933-5125 deokhyun.han@gmail.com
Principal Investigator: Deokhyun Han, M.D.

Sponsors and Collaborators

Samsung Medical Center

Taewoong Medical Co., Ltd.

Investigators

Principal Investigator:	Deok Hyun Han, M.D.	Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Principal Investigator:	Hyeong keun Park, M.D. Ph.D.	Department of Urology, Asan Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	HAN, DEOK HYUN, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01788865 History of Changes
Other Study ID Numbers:	URT-001
First Posted:	February 11, 2013
Last Update Posted:	February 11, 2013
Last Verified:	February 2013

Keywords provided by HAN, DEOK HYUN, Samsung Medical Center:

covered Metal stent; ureteral obstruction

Additional relevant MeSH terms:

Ureteral Obstruction; Ureteral Diseases; Urologic Diseases