Patency and Safety of the Drug Eluting Covered Biliary St... | NCT01512563

Studies
Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent

NCT01512563

Sponsor

Taewoong Medical Co., Ltd.

Status

Completed

Last Update Posted

Mar 11, 2020Actual

Enrollment

106Actual

Phase

Not Applicable

Conditions

Biliary Stricture
Malignant Neoplasms

Interventions

Biliary stent

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jan 11, 2012

First Submission Date that Met QC Criteria

Jan 15, 2012

First Posted Date

Jan 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Detailed Description

Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paclitaxel ElutingCovered Metal Stent	Experimental		Device: Biliary stent
Covered Metal Stent	Active Comparator		Device: Biliary stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biliary stent	Device	palliative treatment for malignant patients	Covered Metal Stent Paclitaxel ElutingCovered Metal Stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accumulative Patency Rate		6 month

Secondary Outcomes

Measure	Description	Time Frame
Accumulative Survival Rate		6 months
Complications		6 months
Possibility of Other Treatment after Obstruction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility

Exclusion Criteria:

Patient who have life expectancy under 3 months
Patient who have severe metastasis of Liver or whole body
Patient who previously had surgical biliary drainage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong Ki Lee, Ph.D	Kangnam Severance Hospital	Study Chair
Ho Gak Kim	Catholic University of Daegu School of Medicine	Principal Investigator
Sang Heum Park	Soon Chun Hyang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soon Chun Hyang University Hospital Cheonan		Cheonan			South Korea
Catholic University of Daegu School of Medicine

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided