UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015315
Receipt number R000017813
Scientific Title Clinical study of Robot-assisted surgery using da Vinci Surgical System for mediastinal tumors
Date of disclosure of the study information 2014/10/02
Last modified on 2019/10/07 15:49:20

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Basic information

Public title

Clinical study of Robot-assisted surgery using da Vinci Surgical System for mediastinal tumors

Acronym

Clinical study of Robot-assisted surgery for mediastinal tumors

Scientific Title

Clinical study of Robot-assisted surgery using da Vinci Surgical System for mediastinal tumors

Scientific Title:Acronym

Clinical study of Robot-assisted surgery for mediastinal tumors

Region

Japan


Condition

Condition

mediastinal diseases

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the usability and safety of endoscopic surgery using da Vinci Surgical System for mediastinal diseases

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

overall survival

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Endoscopic surgery using da Vinci Surgical System

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

A case that an operation under the general anesthesia is possible.
A case that a document agrrement by the examination participation.

Key exclusion criteria

none

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Hokka

Organization

Kobe University Graduate School of Medicine, Kobe, Japan

Division name

Division of Thoracic Surgery, Department of Surgery

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, Japan, 81

TEL

078-382-5750

Email

dhokka@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Hokka

Organization

Kobe University Graduate School of Medicine, Kobe, Japan

Division name

Division of Thoracic Surgery, Department of Surgery

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, Japan, 81

TEL

078-382-5750

Homepage URL


Email

dhokka@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine, Kobe, Japan

Institute

Department

Personal name



Funding Source

Organization

Kobe University Graduate School of Medicine, Kobe, Japan

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

神戸大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 02 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

Terminated

Date of protocol fixation

2013 Year 09 Month 25 Day

Date of IRB

2013 Year 09 Month 25 Day

Anticipated trial start date

2015 Year 12 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 02 Day

Last modified on

2019 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017813


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name