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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01788865
• Collaborator: Taewoong Medical Co., Ltd. (Industry)
• Enrollment: 92
• Locations: 2
• Arm: 1
• Duration (Months): 24
• Patients Per Site: 46
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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

1. 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

• Study Type: Interventional
• Anticipated Enrollment: 92 participants
• Allocation: N/A
• 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: Jun 1, 2012
• Anticipated Primary Completion Date: Jun 1, 2014
• Anticipated Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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)

3. Adverse Event [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 [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 [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) [1, 3, 6, 9, 12 months]

   Comparative analysis of USSQ : before procedure and after procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Patients with no previous ureteral metal stenting procedure experience.

2. Patients with more than 6 months of life expectancy

3. 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

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of
2	Samsung Medical Center	Seoul		Korea, Republic of

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HAN, DEOK HYUN, HAN, DEOK HYUN, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01788865
• Other Study ID Numbers: URT-001
• First Posted: Feb 11, 2013
• Last Update Posted: Feb 11, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by HAN, DEOK HYUN, HAN, DEOK HYUN, Samsung Medical Center: covered Metal stent; ureteral obstruction
• Additional relevant MeSH terms: Ureteral Obstruction

Study Results

No Results Posted as of Feb 11, 2013