Clinical trial NCT01788865: Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA) in Ureteral Obstruction
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ureteral Obstruction
Keywords: covered Metal stent
ureteral obstruction
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Taewoong Medical Co., Ltd.
First posted: 2013-02-11
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Primary patency rate
timeFrame: 12 months
Secondary outcomes:
measure: Technical success rate
timeFrame: 1week, 1 month
measure: Final patency rate
timeFrame: 12 months
measure: Adverse Event
timeFrame: 1week, 1, 3, 6, 9, 12 months
measure: Predictive Risk Factors for Primary patency rate
timeFrame: 12 months
measure: the primary patency rate among different location of distal stent
timeFrame: 12 months
measure: Ureteral stent symptom questionnaire(USSQ)
timeFrame: 1, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Deok Hyun Han, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Urology, Asan Medical Center
name: Hyeong keun Park, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: