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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01413386
Other study ID # MIRA-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2011
Est. completion date April 23, 2013

Study information

Verified date March 2020
Source Taewoong Medical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.


Description:

Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.


Recruitment information / eligibility

Status Terminated
Enrollment 74
Est. completion date April 23, 2013
Est. primary completion date April 18, 2013
Accepts healthy volunteers No
Gender All
Age group 19 Years to 90 Years
Eligibility Inclusion Criteria:

- Patient who submitted a written informed consent for the this trial, and 18 ~ 90 years old

- Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion

- Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis

- Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly

- Patient who have life expectancy at least longer than 3 months (Karnofsky score >60%)

Exclusion Criteria:

- Patient who previously had surgical biliary drainage

- Patient who carrying bleeding disorder

- Patient who have combined Hilar and/or intra-hepatic duct cancer

- Patient who is improper to endoscopic treatment

Study Design


Intervention

Device:
biliary stent
palliative treatment for malignant patients

Locations

Country Name City State
Korea, Republic of In Ha University Hospital Incheon In Chun
Korea, Republic of Kangnam Severance Hospital Kangnam Seoul
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Jong Taek, Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accumulative Patency Rate 6 months
Secondary Accumulative Survival Rate 6 months
Secondary Stent migration rate 6 months
Secondary Possibility of Other Treatment after Obstruction 6 months
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