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

Ureteral Obstruction Clinical Trial

— UVENTA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01788865
• Other study ID #: URT-001
• Status: Recruiting
• Phase: Phase 4
• First received: February 7, 2013
• Last updated: February 7, 2013
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2013
• Source: Samsung Medical Center
• Contact: Deok Hyun Han, M.D.
• Phone: 82-2-3410-6431
• Email: deokhyun.han[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ureteral Obstruction

Intervention

Device:
• cSEMS(Covered self-expandable dual-layered metal stent) implant

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Taewoong Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Adverse Event	Rate of total Adverse Events and Adverse Events relevant to Investigational Device	1week, 1, 3, 6, 9, 12 months	Yes
Secondary	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	No
Secondary	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	No
Secondary	Ureteral stent symptom questionnaire(USSQ)	Comparative analysis of USSQ : before procedure and after procedure	1, 3, 6, 9, 12 months	No