Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA) in Ureteral Obstruction (UVENTA)
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ClinicalTrials.gov Identifier: NCT01788865 |
Recruitment Status
: Unknown
Verified February 2013 by HAN, DEOK HYUN, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted
: February 11, 2013
Last Update Posted
: February 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ureteral Obstruction | Device: cSEMS(Covered self-expandable dual-layered metal stent) implant | Phase 4 |
Prospective, Multi-center, open label, single arm Study
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Treatment
- Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction
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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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: cSEMS
Patients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant
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Device: cSEMS(Covered self-expandable dual-layered metal stent) implant
Other Name: UVENTA™ Ureteral Stent, Taewoong medical
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- 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)
- 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
- 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)
- Adverse Event [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]difference of the primary patency between the group of Distal stent located in urinary bladder and ureter
- Ureteral stent symptom questionnaire(USSQ) [ Time Frame: 1, 3, 6, 9, 12 months ]Comparative analysis of USSQ : before procedure and after procedure

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20~80 years
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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
- Patients with no previous ureteral metal stenting procedure experience.
- Patients with more than 6 months of life expectancy
- Patients understanding the objective of the study and who are willing to sign a consent
Exclusion Criteria:
- Patients with Urothelial Carcinoma
- Patients with bladder invasion of malignant tumor
- Patients with bladder dysfunction or obstruction of lower urinary tract
- one or more times Recurrent Urinary stone in the last 3 years
- 2 or more times upper urinary tract infection without upper urinary tract obstruction
- Karnofsky scores < 60
- Patients with Bacteriuria
- Inadequate Patient to participate in the study as judged by the investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788865
Contact: Deok Hyun Han, M.D. | 82-2-3410-6431 | deokhyun.han@gmail.com |
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. |
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 |
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 Key Record Dates |
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 |