UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012920 |
|---|---|
| Receipt number | 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 09:10:16 |
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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
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
nokochi3@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015109
