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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027085
Receipt No. R000031046
Scientific Title The Accuracy and Usability of intraoperative ultrasonography (Real-time Virtual Sonography) for liver surgery
Date of disclosure of the study information 2017/05/01
Last modified on 2017/04/21

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Basic information
Public title The Accuracy and Usability of intraoperative ultrasonography (Real-time Virtual Sonography) for liver surgery
Acronym RVS study for liver surgery
Scientific Title The Accuracy and Usability of intraoperative ultrasonography (Real-time Virtual Sonography) for liver surgery
Scientific Title:Acronym RVS study for liver surgery
Region
Japan

Condition
Condition liver tumor, pancreatic tumor, tumor of biliary system
Classification by specialty
Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluating the accuracy and clinical usability of RVS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes positional error between CT and IOUS images
Key secondary outcomes Requiring tim for registration time and others

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1 years-old <
Age-upper limit
120 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent laparotomy and liver mobilization
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Takamoto
Organization Japanese Red Cross Medical Center
Division name Hepatobiliary-pancreatic and liver transplantation surgery
Zip code
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL 0334001311
Email takamoto@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Takamoto
Organization Japanese Red Cross Medical Center
Division name Hepatobiliary-pancreatic and liver transplantation surgery
Zip code
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL 0334001311
Homepage URL
Email takamoto@nifty.com

Sponsor
Institute Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization Hitachi Aloka Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 462
Org. issuing International ID_1 none
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本赤十字社医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 05 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 Open public recruiting
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 30 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
2023 Year 09 Month 30 Day
Date trial data considered complete
2023 Year 09 Month 30 Day
Date analysis concluded
2023 Year 12 Month 31 Day

Other
Other related information nothing paticular

Management information
Registered date
2017 Year 04 Month 21 Day
Last modified on
2017 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031046

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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