UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring tissue circulation with flexible optical probe
Acronym	Monitoring tissue circulation with flexible optical probe
Scientific Title	Monitoring tissue circulation with flexible optical probe
Scientific Title:Acronym	Monitoring tissue circulation with flexible optical probe
Region	Japan

Condition
Condition	Reconstruction patients using microsurgery
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the efficacy using flexible optical probe to monitor tissue circulation after surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Data (pulse wave, temperature, and color) obtained from device which reflex tissue circulation.
Key secondary outcomes	Clinical findings, clinical pictures, and clinical endpoints.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Application of device
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-Patients who will have cosmetic/functional reconstruction surgery -Patients 18 years or older -Patients who have been explained about the study, and have agreed with it in written format.
Key exclusion criteria	-Pregnant woman -Nursing mothers -Patients who are not capable to corporate to this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Tomioka
Organization	University of Tokyo
Division name	Department of Plastic Surgery
Zip code	1138655
Address	Hongo 7-3-1 CRC2F, Bunkyo City, Tokyo
TEL	03-5800-8670
Email	tomiokay-pla@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Yukiko Middle name Last name Tahara
Organization	University of Tokyo
Division name	Department of Plastic Surgery
Zip code	1138655
Address	Hongo 7-3-1 CRC2F, Bunkyo City, Tokyo
TEL	03-5800-8670
Homepage URL
Email	tatenmonitor-office@umin.ac.jp

Sponsor
Institute	University of Tokyo
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB Tokyo Univ
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo
Tel	03-5841-0818
Email	ethics@m.u-tokyo.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	東京大学医学部附属病院（東京都）、東京医科歯科大学医学部附属病院（東京都）、自治医科大学医学部附属病院（栃木県）、国立がん研究センター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 27 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	27
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	Completed
Date of protocol fixation	2017 Year 02 Month 08 Day
Date of IRB	2017 Year 02 Month 06 Day
Anticipated trial start date	2017 Year 07 Month 27 Day
Last follow-up date	2018 Year 09 Month 11 Day
Date of closure to data entry	2018 Year 10 Month 29 Day
Date trial data considered complete	2018 Year 11 Month 05 Day
Date analysis concluded	2018 Year 12 Month 14 Day

Other
Other related information

Management information
Registered date	2017 Year 07 Month 27 Day
Last modified on	2019 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032515

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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