NCT01788865

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

February 7, 2013

Last Update Submit

February 7, 2013

Conditions

Ureteral Obstruction

Keywords

covered Metal stentureteral obstruction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Technical success rate

    1week, 1 month

  • Final patency rate

    12 months

  • Adverse Event

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

  • Predictive Risk Factors for Primary patency rate

    12 months

  • the primary patency rate among different location of distal stent

    12 months

  • +1 more secondary outcomes

Study Arms (1)

cSEMS

EXPERIMENTAL

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

Interventions

cSEMS(Covered self-expandable dual-layered metal stent) implantDEVICE
Also known as: UVENTA™ Ureteral Stent, Taewoong medical
cSEMS

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Ureteral Obstruction

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deok Hyun Han, M.D.

CONTACT

82-2-3410-6431deokhyun.han@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HAN, DEOK HYUN

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

KR(2)