UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020883 |
|---|---|
| Receipt number | R000023632 |
| Scientific Title | Function evaluation of the new intraoperative projector machine using a fluorescence color system |
| Date of disclosure of the study information | 2016/02/12 |
| Last modified on | 2018/05/05 09:28:11 |
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Basic information
Public title
Function evaluation of the new intraoperative projector machine using a fluorescence color system
Acronym
Function evaluation of the new intraoperative projector machine using a fluorescence color system (MIPS2)
Scientific Title
Function evaluation of the new intraoperative projector machine using a fluorescence color system
Scientific Title:Acronym
Function evaluation of the new intraoperative projector machine using a fluorescence color system (MIPS2)
Region
| Japan |
Condition
Condition
Donor and recipient of living donor liver transplantation, multiple liver metastases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the diagnostic accuracy of a near-infrared fluorescence color system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of perfusion area of graft liver in liver transplantation surgery, visualization of the tumors which are difficult to recognize with the naked eyes
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
To use the projector machine using a fluorescence color system
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Written informed consent
Key exclusion criteria
Pregnancy or suspicion of pregnancy.
History of hypersensitivity to ICG.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Seo |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address
54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL
075-751-3608
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto Nishino |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address
54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL
075-751-3608
Homepage URL
hnishino@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamada Shadowless Lamp Corporation
Panasonic Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 12 | 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
| 2016 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023632
