UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028399 |
|---|---|
| Receipt number | R000032515 |
| Scientific Title | Monitoring tissue circulation with flexible optical probe |
| Date of disclosure of the study information | 2017/07/27 |
| Last modified on | 2019/07/29 15:23:34 |
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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
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
tatenmonitor-office@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032515
