Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2013 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Taewoong Medical Co., Ltd.
Information provided by (Responsible Party):
HAN, DEOK HYUN, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01788865
First received: February 7, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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 Intervention Phase
Ureteral Obstruction
 Device: cSEMS(Covered self-expandable dual-layered metal stent) implant
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Primary patency rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1week, 1 month ] [ Designated as safety issue: No ]
    Rate of technical success(each Ureter) resolving the stenosis and passing the contrast medium from the kidney to urinary bladder

  • Final patency rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1week, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: Yes ]
    Rate of total Adverse Events and Adverse Events relevant to Investigational Device

  • Predictive Risk Factors for Primary patency rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    difference of the primary patency between the group of Distal stent located in urinary bladder and ureter

  • Ureteral stent symptom questionnaire(USSQ) [ Time Frame: 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Comparative analysis of USSQ : before procedure and after procedure
Estimated Enrollment: 92
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: UVENTA™ Ureteral Stent, Taewoong medical

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
Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788865

Contacts
Contact: Deok Hyun Han, M.D. 82-2-3410-6431 deokhyun.han@gmail.com

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

No publications provided

Responsible Party: HAN, DEOK HYUN, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01788865     History of Changes
Other Study ID Numbers: URT-001
Study First Received: February 7, 2013
Last Updated: February 7, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
covered Metal stent
ureteral obstruction

Additional relevant MeSH terms:
Ureteral Obstruction
Ureteral Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on March 03, 2015