UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003126 |
|---|---|
| Receipt number | R000003791 |
| Scientific Title | A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor |
| Date of disclosure of the study information | 2010/02/01 |
| Last modified on | 2013/02/06 15:48:40 |
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Basic information
Public title
A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor
Acronym
A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor
Scientific Title
A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor
Scientific Title:Acronym
A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor
Region
| Japan |
Condition
Condition
The pancreatic and biliary diseases including the dysfunction of sphincter of Oddi
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validity and safety of measuring the pressure of sphincter of Oddi
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The pressure of sphincter of Oddi
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measuring the pressure of sphincter of Oddi
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who have the pancreatic and biliary diseases including Sphincter of Oddi dysfunction
Key exclusion criteria
1)Patients without written informed consent
2)Patients with severe concurrent diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromu Kutsumi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6980
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Kobe University Graduate School of Medicine
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
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
| 2010 | Year | 02 | 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
| 2009 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 01 | Day |
Last modified on
| 2013 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003791
