UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016270 |
|---|---|
| Receipt number | R000018799 |
| Scientific Title | A phase ll study of robot assisted lobectomy for lung cancer |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2020/02/12 10:48:48 |
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Basic information
Public title
A phase ll study of robot assisted lobectomy for lung cancer
Acronym
A phase ll study of robot assisted lobectomy for lung cancer
Scientific Title
A phase ll study of robot assisted lobectomy for lung cancer
Scientific Title:Acronym
A phase ll study of robot assisted lobectomy for lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety of robotic assisted thoracoscopic lobectomy using da Vinci surgical system for primary lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Safety
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
| Device,equipment |
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients with lung cancer
2. The patients who have not undergone open thoracotomy
3. patinets maintaining the function the main organ
4. A case that document agreement by the examination participation
Key exclusion criteria
Patients with severe or complicated medical conditions, not allowing participation into this protocol
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhisa Ohde |
Organization
Shizuoka Cancer Center Hospital
Division name
Division of Thoracic Surgery
Zip code
Address
1007, Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL
055-989-5222
y.ode@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Kojima |
Organization
Shizuoka Cancer Center Hospital
Division name
Division of Thoracic Surgery
Zip code
Address
1007, Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
h.kojima@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 01 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 02 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018799
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
