![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028399 |
Receipt No. | 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 |
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 |
|
Condition | ||
Condition | Reconstruction patients using microsurgery | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |