UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002848 |
|---|---|
| Receipt number | R000003477 |
| Scientific Title | New tequnique for peripheral nerve gap:direct lengthening of both nerve stumps |
| Date of disclosure of the study information | 2009/12/05 |
| Last modified on | 2019/12/12 11:33:30 |
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Basic information
Public title
New tequnique for peripheral nerve gap:direct lengthening of both nerve stumps
Acronym
Direct lengthening of both nerve stumps
Scientific Title
New tequnique for peripheral nerve gap:direct lengthening of both nerve stumps
Scientific Title:Acronym
Direct lengthening of both nerve stumps
Region
| Japan |
Condition
Condition
peripheral nerve injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and effect of nerve lengthening methods
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
safety of nerve lengthening methods
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
| Device,equipment |
Interventions/Control_1
treatment for peripheral nerve gap
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
peripheral nerve gap
Key exclusion criteria
DM,peripheral nerve disease, serious illnesses, malignat disease, pregnancy,have other experiences, not agreed
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hara |
Organization
University of Tsukuba
Division name
Comprehensive Human Sciences
Zip code
3058577
Address
1-1-1, Tennoudai, Tsukuba, Ibaraki
TEL
0298533219
yukihara@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hara |
Organization
Clinical Medicine
Division name
Orthopaedics
Zip code
3058577
Address
1-1-1, Tennnoudai, Tsukuba, Ibaraki, Japan
TEL
029-853-3219
Homepage URL
seikei@md.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
T-CReDO
Address
1-1-1, Tennnoudai, Taukuba, Ibaraki
Tel
029-853-3914
kenkyu@un.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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 05 | 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
| 2009 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003477
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
