UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016813
Receipt No. R000019515
Scientific Title Prospective clinical study of EUS-guided biliary drainage using novel balloon catheter
Date of disclosure of the study information 2015/04/01
Last modified on 2015/12/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective clinical study of EUS-guided biliary drainage using novel balloon catheter
Acronym Prospective clinical study of EUS-guided biliary drainage using novel balloon catheter
Scientific Title Prospective clinical study of EUS-guided biliary drainage using novel balloon catheter
Scientific Title:Acronym Prospective clinical study of EUS-guided biliary drainage using novel balloon catheter
Region
Japan

Condition
Condition unresectable mlignant biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes technical success rate
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient who is needed to recive EUS-guided biliary drainage
Key exclusion criteria 1) preggy
2) rejection by patients
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Ogura
Organization Osaka Medical College
Division name Gastroenterology
Zip code
Address 2-7 Daigakuchou, Takatsukishi
TEL 072-683-1221
Email oguratakeshi0411@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Ogura
Organization Osaka Medical Colledge
Division name Gastroenterology
Zip code
Address 2-7 Daigakuchou, Takatsukishi, Osaka
TEL 072-683-1221
Homepage URL
Email oguratakeshi0411@yahoo.co.jp

Sponsor
Institute Osaka Medical Colledge
Institute
Department

Funding Source
Organization Osaka Medical Colledge
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2015 Year 03 Month 16 Day
Last modified on
2015 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019515

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.