UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012917 |
|---|---|
| Receipt number | R000015102 |
| Scientific Title | A prospective study for assessing the effectiveness and safety of pulmonary resection for malignant lung tumors by using the surgical robot system (da Vinci S) |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2018/07/27 16:12:06 |
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Basic information
Public title
A prospective study for assessing the effectiveness and safety of pulmonary resection for malignant lung tumors by using the surgical robot system (da Vinci S)
Acronym
A prospective study for assessing the effectiveness and safety of pulmonary resection for malignant lung tumors by using the surgical robot system (da Vinci S)
Scientific Title
A prospective study for assessing the effectiveness and safety of pulmonary resection for malignant lung tumors by using the surgical robot system (da Vinci S)
Scientific Title:Acronym
A prospective study for assessing the effectiveness and safety of pulmonary resection for malignant lung tumors by using the surgical robot system (da Vinci S)
Region
| Japan |
Condition
Condition
malignant lung tumors
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 pulmonary resection for malignant lung tumors by using the surgical robot system (da Vinci S)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Completeness of the resection of pulmonary tumors
Key secondary outcomes
Operation time, Mortality and morbidity, Length of hospital stay, Degree of postpperative pain, pathological findings
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 pulmonary malignant tumor
Key exclusion criteria
Patients with tumor direct invasion to malignant navor organs, 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
052-744-2375
k-yokoi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shota Nakamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Thoracic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2375
Homepage URL
shota197065@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Thoracic Surgery
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | 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
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | 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
| 2014 | Year | 01 | Month | 22 | Day |
Last modified on
| 2018 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015102
