UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014830 |
|---|---|
| Receipt number | R000017235 |
| Scientific Title | A study about the usefulness of new flexible device to control organs |
| Date of disclosure of the study information | 2014/08/13 |
| Last modified on | 2014/09/23 22:33:13 |
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Basic information
Public title
A study about the usefulness of new flexible device to control organs
Acronym
A study about the usefulness of new flexible device to control organs
Scientific Title
A study about the usefulness of new flexible device to control organs
Scientific Title:Acronym
A study about the usefulness of new flexible device to control organs
Region
| Japan |
Condition
Condition
objectives to a digestive surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the living body where the lymph and the blood are exuding, I validate the effectives of the form of this device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
obtaining a satisfactory field in operation by using this device
Key secondary outcomes
safety in using this device
Base
Study type
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the new device
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
the surgery cases of a digestive surgery
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Ikoma |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Digestive Surgery
Zip code
Address
465 Kajii-cho, Kamigyo-ku Kyoto
TEL
075-251-5527
ikoma@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Ikoma |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Digestive Surgery
Zip code
Address
465 Kajii-cho, Kamigyo-ku Kyoto
TEL
075-251-5527
Homepage URL
ikoma@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Division of Digestive Surgery
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine, Division of Digestive Surgery
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
京都府立医科大学消化器外科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 11 | Day |
Last modified on
| 2014 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017235
