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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034341
Receipt No. R000039140
Scientific Title Exploratory study of Laparoscopic Navigation System with Real-time Virtual Sonography
Date of disclosure of the study information 2018/10/01
Last modified on 2018/10/01

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Basic information
Public title Exploratory study of Laparoscopic Navigation System with Real-time Virtual Sonography
Acronym A Novel Intraoperative Navigation System for Laparoscopic Liver Resection Using Real-Time Virtual Sonography
Scientific Title Exploratory study of Laparoscopic Navigation System with Real-time Virtual Sonography
Scientific Title:Acronym A Novel Intraoperative Navigation System for Laparoscopic Liver Resection Using Real-Time Virtual Sonography
Region
Japan

Condition
Condition Exploratory study
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the differences between the simulated dissecting domain and the authentic dissecting domain.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes The differences between the simulated dissecting domain and the authentic dissecting domain are within 10mm in mean.
Key secondary outcomes Evaluated factors are within the tolerance range.

Base
Study type Others,meta-analysis etc

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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Scheduled hepatic resection with preoperative images with computed tomography or magnetic resonance imaging, (2) Performance status 0 or 1, (3) The following standards of marrow functions: white blood cell count>/=3500mm3, haemoglobn>/=10.0g/dl, Platelet>/=80000/mm3, (4) The following standards of liver functions: total bilirubin level<2.0mg/dl, aspartate aminotransferase level<100U/l, alanine aminotransferase<100U/l, liver damage A or B.
Key exclusion criteria apprication withdrawal
Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Sakata
Organization Japan Seafares Relief Association Ekisaikai Moji Hospital
Division name Surgery
Zip code
Address 1-3-1 Kiyotaki Mojiku Kitakyushu Fukuoka, 801-8505
TEL 093-321-0984
Email atak51ks331007@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Sakata
Organization Japan Seafares Relief Association Ekisaikai Moji Hospital
Division name Surgery
Zip code
Address 1-3-1 Kiyotaki Mojiku Kitakyushu Fukuoka, Japan, 801-8505
TEL 093-321-0984
Homepage URL
Email atak51ks331007@gmail.com

Sponsor
Institute JCHO Shimonoseki Medical Center
Institute
Department

Funding Source
Organization Hitachi Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 Japan Seafares Relief Association Ekisaikai Moji Hospital(Fukuoka), JCHO Shimonoseki Medical Center(Yamaguchi)

Other administrative information
Date of disclosure of the study information
2018 Year 10 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information The differences between the simulation plane and the authentic plane were conventionally investigated after dividing the surrounding ligaments laparoscopically. The authentic dissecting plane was estimated by a staining method with contrast-enhancement ultrasonography and near-infrared ray vision system (Photo Dynamic Rye(R), HAMAMATSU Photonics). The differences were measured as a request of errors detected every 5 degrees of the plane image from the center in in a real excision domain.

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039140

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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