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

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 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


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

Value
https://center6.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