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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009696
Receipt No. R000011355
Scientific Title A prospective study for assessing the effectiveness and safety of mediastinal tumor resection and extended thymectomy for myasthenia gravis by using the surgical robot system (da vinci S)
Date of disclosure of the study information 2013/03/01
Last modified on 2017/07/09

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Basic information
Public title A prospective study for assessing the effectiveness and safety of mediastinal tumor resection and extended thymectomy for myasthenia gravis by using the surgical robot system (da vinci S)
Acronym Mediastinal tumor resection and extended thymectomy by using the surgical robot system
Scientific Title A prospective study for assessing the effectiveness and safety of mediastinal tumor resection and extended thymectomy for myasthenia gravis by using the surgical robot system (da vinci S)
Scientific Title:Acronym Mediastinal tumor resection and extended thymectomy by using the surgical robot system
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to assess the effectiveness and safety of mediastinal tumor resection and extended thymectomy for myasthenia gravis by using the surgical robot system (da vinci S)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Completeness of the resection of mediastinal tumors or thymus and surrounding adipose tissues
Key secondary outcomes Operation time, Mortality and morbidity, Length of hospital stay, Degree of postoperative pain

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 Surgical treatment by using the surgical robot system (da vinci S)
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 Patients with a document agreement, who is recommended for tumor resection for the mediastinal mass or extended thymectomy for myasthenia gravis
Key exclusion criteria Patients with invasive malignant mediastinal tumor, a history of thoracotomy, or cardio-pulmonary dysfunction, Patients without an informed consent
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Yokoi
Organization Nagoya University Graduate School of Medicine
Division name Department of Thoracic Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2376
Email k-yokoi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Kawaguchi
Organization Nagoya University Graduate School of Medicine
Division name Department of Thoracic Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2376
Homepage URL
Email gucci@med.nagoya-u.ac.jp

Sponsor
Institute Department of Thoracic Surgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Hospital
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 名古屋大学附属病院

Other administrative information
Date of disclosure of the study information
2013 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 Completed
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 04 Day
Last modified on
2017 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011355

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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