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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002848
Receipt No. 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 2018/12/11

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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
Middle name
Last name Yuki Hara
Organization University of Tsukuba
Division name Comprehensive Human Sciences
Zip code
Address 1-1-1, Tennoudai, Tsukuba, Ibaraki
TEL 0298533219
Email yukihara@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Hara
Organization Clinical Medicine
Division name Orthopaedics
Zip code
Address 1-1-1, Tennnoudai, Tsukuba, Ibaraki, Japan
TEL 029-853-3219
Homepage URL
Email seikei@md.tsukuba.ac.jp

Sponsor
Institute Tsukuba University Hospital
Institute
Department

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
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 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
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003477

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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