UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031485 |
|---|---|
| Receipt number | R000035939 |
| Scientific Title | Clinical study of Robot-assisted surgery using da Vinci S or Si HD Surgical System for primary lung cancer |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/03/09 10:29:41 |
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Basic information
Public title
Clinical study of Robot-assisted surgery using da Vinci S or Si HD Surgical System for primary lung cancer
Acronym
Clinical study of Robot-assisted surgery for primary lung cancer
Scientific Title
Clinical study of Robot-assisted surgery using da Vinci S or Si HD Surgical System for primary lung cancer
Scientific Title:Acronym
Clinical study of Robot-assisted surgery for primary lung cancer
Region
| Japan |
Condition
Condition
Primary Lung Cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of endoscopic surgery using da Vinci S or Si HD Surgical System for primary lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Incidence of intra- and post-operative adverse events
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
Endoscopic surgery using da Vinci S or Si HD Surgical System
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with clinical stage I or II lung cancer
2. The patients who have not undergone open thoracotomy
3. Patients maintaining the functions of the main organs
4. A case that an operation under the general anesthesia is possible
5. A case that a document agreement by the examination participation
Key exclusion criteria
1. A case of 19 years or younger
2. Pregnant or potentially women, nursing women
3. Past history of the open thoracotomy
4. When it is judged that thoracoscopic surgery is inadequate (i.e. great vessel invasion).
5. Patients with psychiatric diseases
6. A case that no document agreement by the examination participation
7. 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 | Masato Kanzaki |
Organization
Tokyo Women's Medical University of Medicine
Division name
Department of Surgery I
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
0333538111
kanzaki.masato@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Maeda |
Organization
Tokyo Women's Medical University of Medicine
Division name
Department of Surgery I
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
0333538111
Homepage URL
maeda.hideyuki@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University of Medicine, Department of Surgery I
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
| 2018 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | 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
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2018 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035939
