UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011318 |
|---|---|
| Receipt number | R000013264 |
| Scientific Title | Clinical research of a bioinstrumentation using shape deformation of amputated uupper limb |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2021/02/03 09:26:59 |
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Basic information
Public title
Clinical research of a bioinstrumentation using shape deformation of amputated uupper limb
Acronym
Bioinstrumentation of amputated upper limb
Scientific Title
Clinical research of a bioinstrumentation using shape deformation of amputated uupper limb
Scientific Title:Acronym
Bioinstrumentation of amputated upper limb
Region
| Japan |
Condition
Condition
Amputated upper limb
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of our bioinstrumentation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safty, operability and efficacy
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
usage of bioinstrumentation
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
after one year of amputation
Key exclusion criteria
Diabates, peripheral nerve disorder, Complication, pregnancy, malignancy and other infelicity
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hara |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Orthopaedics
Zip code
3058577
Address
1-1-1. Tennodai, Tsukuba, Ibaraki, Japan
TEL
0298533914
yukihara@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hara |
Organization
University of Tsukuba
Division name
Orthopaedics
Zip code
3058577
Address
Tennodai, Tsukuba, Japan
TEL
0298533914
Homepage URL
yukihara@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Koshiyama technology promotion foundation
JKA machine industry promotion assistance business Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of tsukuba hospital
Address
1-1-1tennnoudai tsukuba ibaraki
Tel
0298533219
tcredo@md.tsukuba.ac.jp
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
| 2013 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 30 | Day |
Last modified on
| 2021 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013264
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
