UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009696 |
|---|---|
| Receipt number | 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 10:38:06 |
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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
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
gucci@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011355
