UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034341
Receipt number 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 13:21:05

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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 or person

Institute

JCHO Shimonoseki Medical Center

Institute

Department

Personal name



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

Value
https://center6.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