UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012920
Receipt No. R000015109
Scientific Title A clinical study of the use of a computer-aided surgical navigation `next generation virtual hepatectomy simulation system`
Date of disclosure of the study information 2014/03/01
Last modified on 2017/01/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical study of the use of a computer-aided surgical navigation `next generation virtual hepatectomy simulation system`
Acronym A clinical study of the use of a `next generation virtual hepatectomy simulation system`
Scientific Title A clinical study of the use of a computer-aided surgical navigation `next generation virtual hepatectomy simulation system`
Scientific Title:Acronym A clinical study of the use of a `next generation virtual hepatectomy simulation system`
Region
Japan

Condition
Condition hepatobiliary tumors
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of LIVERSIM compared with SYNAPSE VINCENT on hepatectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Amount of bleeding
Key secondary outcomes Hospitalization
Operative time
Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 To perform hepatectomy using SYNAPSE VINCENT
Interventions/Control_2 To perform hepatectomy using LIVERSIM
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
85 years-old >
Gender Male and Female
Key inclusion criteria (1) Participants who gave written informed consent
(2) Inpatients
Key exclusion criteria (1) Past history of sever infectious disease, heart failure, acute myocardial infarction, respira-
tory failure, liver failure,
renal failure, acute stroke,
Poorly controlled diabetes mellitus
(2) Patients whose doctors determined as inadequate for the study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Ohkohchi
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Suegery
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3221
Email nokochi3@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Ohkohchi
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Surgery
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3221
Homepage URL
Email nokochi3@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
Organization
Division
Category of Funding Organization Self funding
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 筑波大学附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 03 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 Preinitiation
Date of protocol fixation
2014 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 11 Month 30 Day
Date analysis concluded
2018 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 22 Day
Last modified on
2017 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015109

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.