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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010554
Receipt No. R000012340
Scientific Title Spraying bFGF on the cut surface for support of severe damaged fingertip replantation
Date of disclosure of the study information 2013/04/25
Last modified on 2013/04/21

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Basic information
Public title Spraying bFGF on the cut surface for support of severe damaged fingertip replantation
Acronym Spraying bFGF for severe damaged fingertip replantation
Scientific Title Spraying bFGF on the cut surface for support of severe damaged fingertip replantation
Scientific Title:Acronym Spraying bFGF for severe damaged fingertip replantation
Region
Japan

Condition
Condition Fingertip amputation
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve the result of fingertip amputation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Success rate of fingertip replantation
Key secondary outcomes Recovery of sensation and motor function

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
Medicine Maneuver
Interventions/Control_1 Spraying bFGF
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
5 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Severe damaged fingertip amputation
Key exclusion criteria Patients who have a cancer
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensuke TASHIRO
Organization The University of Tokyo
Division name Plastic and Reconstructive Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokyo
Division name Plastic and Reconstructive Surgery
Zip code
Address
TEL
Homepage URL
Email tashirox@gmail.com

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization none
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

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 25 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 No longer recruiting
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 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
2013 Year 04 Month 21 Day
Last modified on
2013 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012340

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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