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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004328
Receipt No. R000005186
Scientific Title Clinical utility of robotic surgery (the da Vinci® surgical system; standard and S) for the treatment of lung and mediastinal disease
Date of disclosure of the study information 2010/10/05
Last modified on 2020/10/12

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Basic information
Public title Clinical utility of robotic surgery (the da Vinci® surgical system; standard and S) for the treatment of lung and mediastinal disease
Acronym Clinical utility of robotic surgery for the treatment of lung and mediastinal disease
Scientific Title Clinical utility of robotic surgery (the da Vinci® surgical system; standard and S) for the treatment of lung and mediastinal disease
Scientific Title:Acronym Clinical utility of robotic surgery for the treatment of lung and mediastinal disease
Region
Japan

Condition
Condition lung and mediastinal disease
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We use the da Vinci ® Surgical System for thoracic diseases and review future possibilities and problems of robotic surgery for thoracic surgery fields in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Robotic surgery is an effective surgical method.
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
Maneuver
Interventions/Control_1 robotic surgery
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria general condition good(possible of open thoracotomy)
Key exclusion criteria general condition poor
past history of the open thoracotomy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikeda Norihiko
Organization Tokyo medical university
Division name surgery 1
Zip code
Address 6-7-1 Nishi-shinjuku Shinjukuku, Tokyo
TEL 03-3342-6111
Email surgery1@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kajiwara Naohiro
Organization surgeru 1
Division name thoracic surgery
Zip code
Address kajiwara@tokyo-med.ac.jp
TEL 03-3342-6111
Homepage URL
Email kajiwara@tokyo-med.ac.jp

Sponsor
Institute Tokyo medical university, department of general thoracic surgery
Institute
Department

Funding Source
Organization Tokyo medical university
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 東京医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We performed robotic surgery using the da Vinci for 18 mediastinal tumors and a lung cancer. The study is still going in the process.
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 Completed
Date of protocol fixation
2009 Year 09 Month 30 Day
Date of IRB
2009 Year 09 Month 30 Day
Anticipated trial start date
2009 Year 10 Month 30 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 05 Day
Last modified on
2020 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005186

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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