UMIN-CTR Clinical Trial

Basic information
Public title	study of the vascular network with color doppler ultrasonography
Acronym	study of the vascular network with color doppler ultrasonography
Scientific Title	study of the vascular network with color doppler ultrasonography
Scientific Title:Acronym	study of the vascular network with color doppler ultrasonography
Region	Japan

Condition
Condition	Diseases needed reconstruction with flaps.
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of perforators using color doppler ultrasonography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Color doppler ultrasonographic image, clinical anatomy, information obrained from operation
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Interventions/Control_6
Interventions/Control_7
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	0 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Reconstruction with flaps for defects. 2) Informed consent was obtained 3) If the patient is under 20 years old, does not have sufficient judgement or conscious mind, then famiries agreement is needed.
Key exclusion criteria	Cases in which informed consent was not obtained.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kensuke Tashiro
Organization	The University of Tokyo Hospital
Division name	Department of Plastic and Reconstructive Surgery
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	tashirox@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Kensuke Tashiro
Organization	The University of Tokyo Hospital
Division name	Department of Plastic and Reconstructive Surgery
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	tashirox@gmail.com

Sponsor
Institute	Department of Plastic and Reconstructive Surgery, The University of Tokyo
Institute
Department

Funding Source
Organization	commission accounting
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	2015 Year 06 Month 02 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	2014 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date	2015 Year 02 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	Analysis of image examination with color doppler Ultrasonography

Management information
Registered date	2015 Year 06 Month 02 Day
Last modified on	2015 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020588

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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