UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016248 |
|---|---|
| Receipt number | R000018855 |
| Scientific Title | Clinical study of Robot-assisted thoracoscopic surgery using da Vinci Si Surgical System for myasthenia gravis |
| Date of disclosure of the study information | 2015/01/19 |
| Last modified on | 2018/07/22 14:39:04 |
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Basic information
Public title
Clinical study of Robot-assisted thoracoscopic surgery using da Vinci Si Surgical System for myasthenia gravis
Acronym
Clinical study of Robot-assisted thoracoscopic surgery for myasthenia gravis
Scientific Title
Clinical study of Robot-assisted thoracoscopic surgery using da Vinci Si Surgical System for myasthenia gravis
Scientific Title:Acronym
Clinical study of Robot-assisted thoracoscopic surgery for myasthenia gravis
Region
| Japan |
Condition
Condition
myasthenia gravis
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the usability and safety of Robot-assisted thoracoscopic surgery using da Vinci Si Surgical System for myasthenia gravis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
hospitalization
Key secondary outcomes
operative time/amount of bleeding/symptom improvement/adverse events in the perioperative period/overall survival/medication-free remission
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
da Vinci Si
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
1.Patients maintaining the functions of the main organs.
2.A case that an operation under the general anesthesia is possible.
3.A case that a document agrrement by the examination participation.
Key exclusion criteria
1.Pregnant or potentially women, nursing women
2.Past history of the open thoracotomy
3.malignant mediastinal tumors with invasion to adjacent organs.
4.Patients with psychiatric diseases
5.Patients with severe or complicated medical conditions, not allowing participation into this protocol
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Hanaoka |
Organization
Shiga University of Medical Science
Division name
Department of thoracic surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-2244
hanaoka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Hanaoka |
Organization
Shiga University of Medical Science
Division name
Department of thoracic surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-2244
Homepage URL
hanaoka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 19 | 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
| 2015 | Year | 01 | Month | 17 | Day |
Last modified on
| 2018 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018855
