UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010554
Receipt number 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 16:53:22

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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 or person

Institute

The University of Tokyo

Institute

Department

Personal name



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

Value
https://center6.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