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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027289
Receipt No. R000031078
Scientific Title The study of utility and safety of robot-assisted thoracic surgery using da Vinci for lung tumor and mediastinal tumor
Date of disclosure of the study information 2017/05/10
Last modified on 2019/05/11

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Basic information
Public title The study of utility and safety of robot-assisted thoracic surgery using da Vinci for lung tumor and mediastinal tumor
Acronym The study of robot-assisted thoracic surgery
Scientific Title The study of utility and safety of robot-assisted thoracic surgery using da Vinci for lung tumor and mediastinal tumor
Scientific Title:Acronym The study of robot-assisted thoracic surgery
Region
Japan

Condition
Condition Lung tumor, Mediastinal tumor
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the utility and safety of robot-assisted thoracic surgery using da Vinci for lung tumor and mediastinal tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The adverse event of robot-assisted thoracic surgery using da Vinci during
Key secondary outcomes Surgical outcomes(operative time, amount of bleeding, conversion to thoracotomy or video-assisted thoracic surgery)

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
Maneuver
Interventions/Control_1 RObot-assisted thoracic surgery using da Vinci
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 The operative candidates of video-assisted thoracic surgery for lung tumor and mediastinal tumor
Key exclusion criteria No indication of video-assisted thoracic surgery
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Hidetaka
Middle name
Last name Uramoto
Organization Kanazawa Medical University
Division name Department of Thoracic Surgery
Zip code 920-0293
Address 1-1, Daigaku, Uchinada, Ishikawa, Japan
TEL 076-286-2211
Email hidetaka@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name Nozomu
Middle name
Last name Motono
Organization Kanazawa Medical University
Division name Department of Thoracic Surgery
Zip code 920-0293
Address 1-1, Daigaku, Uchinada, Ishikawa, Japan
TEL 076-286-2211
Homepage URL
Email motono@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Kanazawa Medical University
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 Institutional Review Boards of Kanazawa Medical University
Address 1-1, Daigaku, Uchinada, Ishikawa, Japan
Tel 0762862211
Email tiken@kanazawa-med.ac.jp

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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 10 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 25 Day
Date of IRB
2017 Year 05 Month 10 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 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
2017 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031078

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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