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

Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA™) in Ureteral Obstruction: Prospective, Multi-center, Open Label Study

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.

Study Overview

• Status: Unknown
• Conditions: Ureteral Obstruction
• Intervention / Treatment: Device: cSEMS(Covered self-expandable dual-layered metal stent) implant

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 Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Deok Hyun Han, M.D.; Phone Number: 82-2-3410-6431; Email: deokhyun.han@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: UVENTA™ Ureteral Stent, Taewoong medical

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Taewoong Medical Co., Ltd.
• Investigators: Principal Investigator: Hyeong keun Park, M.D. Ph.D., Department of Urology, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: covered Metal stent; ureteral obstruction
• Additional Relevant MeSH Terms: Urologic Diseases; Ureteral Diseases; Ureteral Obstruction
• Other Study ID Numbers: URT-001