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

Primary Purpose

Ureteral Obstruction

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Ureteral Obstruction focused on measuring covered Metal stent, ureteral obstruction

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20~80 years
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

Sites / Locations

Asan Medical CenterRecruiting
Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cSEMS

Arm Description

Patients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant

Outcomes

Primary Outcome Measures

Primary patency rate

Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min)

Secondary Outcome Measures

Technical success rate

Rate of technical success(each Ureter) resolving the stenosis and passing the contrast medium from the kidney to urinary bladder

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)

Adverse Event

Rate of total Adverse Events and Adverse Events relevant to Investigational Device

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.

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

Ureteral stent symptom questionnaire(USSQ)

Comparative analysis of USSQ : before procedure and after procedure

Full Information

NCT ID

NCT01788865

First Posted

February 7, 2013

Last Updated

February 7, 2013

Sponsor

Samsung Medical Center

Collaborators

Taewoong Medical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01788865

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

Collaborators

Taewoong Medical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

Detailed Description

Prospective, Multi-center, open label, single arm Study Treatment - Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ureteral Obstruction

Keywords

covered Metal stent, ureteral obstruction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cSEMS

Arm Type

Experimental

Arm Description

Patients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

UVENTA™ Ureteral Stent, Taewoong medical

Primary Outcome Measure Information:

Title

Primary patency rate

Description

Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Technical success rate

Description

Rate of technical success(each Ureter) resolving the stenosis and passing the contrast medium from the kidney to urinary bladder

Time Frame

1week, 1 month

Title

Final patency rate

Description

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)

Time Frame

12 months

Title

Adverse Event

Description

Rate of total Adverse Events and Adverse Events relevant to Investigational Device

Time Frame

1week, 1, 3, 6, 9, 12 months

Title

Predictive Risk Factors for Primary patency rate

Description

Age, Sex, type of tumor(benign/malignant), length of stenosis, location of stenosis, UVJ cross, balloon catheterization, etc.

Time Frame

12 months

Title

the primary patency rate among different location of distal stent

Description

difference of the primary patency between the group of Distal stent located in urinary bladder and ureter

Time Frame

12 months

Title

Ureteral stent symptom questionnaire(USSQ)

Description

Comparative analysis of USSQ : before procedure and after procedure

Time Frame

1, 3, 6, 9, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20~80 years 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Deok Hyun Han, M.D.

Phone

82-2-3410-6431

deokhyun.han@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deok Hyun Han, M.D.

Organizational Affiliation

Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hyeong keun Park, M.D. Ph.D.

Organizational Affiliation

Department of Urology, Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyeong keoun Park, M.D. Ph.D,

Phone

+82-2-3010-3737

hkpark@amc.seoul.kr

First Name & Middle Initial & Last Name & Degree

Hyeongkeun Park, M.D. Ph.D.

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deokhyun Han, M.D.

Phone

+82-10-9933-5125

deokhyun.han@gmail.com

First Name & Middle Initial & Last Name & Degree

Deokhyun Han, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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