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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024800
Receipt No. R000027178
Scientific Title Function evaluation of the new intraoperative projector machine using a fluorescence color system in identification of the primary hepatic tumors
Date of disclosure of the study information 2016/12/01
Last modified on 2018/05/05

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Basic information
Public title Function evaluation of the new intraoperative projector machine using a fluorescence color system in identification of the primary hepatic tumors
Acronym Function evaluation of the new intraoperative projector machine using a fluorescence color system in identification of the primary hepatic tumors(MIPS3)
Scientific Title Function evaluation of the new intraoperative projector machine using a fluorescence color system in identification of the primary hepatic tumors
Scientific Title:Acronym Function evaluation of the new intraoperative projector machine using a fluorescence color system in identification of the primary hepatic tumors(MIPS3)
Region
Japan

Condition
Condition primary hepatic tumors
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 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
Email rutosa@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
Email hnishino@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department

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
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 京都大学医学部附属病院 肝胆膵・移植外科

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 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 Terminated
Date of protocol fixation
2016 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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

Management information
Registered date
2016 Year 11 Month 11 Day
Last modified on
2018 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027178

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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