UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021258 |
|---|---|
| Receipt number | R000024125 |
| Scientific Title | The clinical experimental study of induction of surgical robot for chest surgery using da Vinci S HD Surgical System, Intuitive Surgical Inc., USA |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2017/03/17 13:22:43 |
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Basic information
Public title
The clinical experimental study of induction of surgical robot for chest surgery using da Vinci S HD Surgical System, Intuitive Surgical Inc., USA
Acronym
The clinical experimental study of robotic chest surgery
Scientific Title
The clinical experimental study of induction of surgical robot for chest surgery using da Vinci S HD Surgical System, Intuitive Surgical Inc., USA
Scientific Title:Acronym
The clinical experimental study of robotic chest surgery
Region
| Japan |
Condition
Condition
Operative candidates of lung cancer and mediastinal tumor.
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To introduce of robotic chest surgery, we are planning to evaluate the safety and usefulness of da Vinci surgical system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety and usefulness of da Vinci surgical system during the chest surgery.
The postoperative physical status including pain, respiratory function and complications, 1 month after the surgery.
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
| Maneuver |
Interventions/Control_1
The chest surgery using the da Vinci 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The operative candidates of thoracic surgery
Key exclusion criteria
No indication of endoscopic surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Matsumoto |
Organization
Kanazawa University
Division name
Department of Thoracic Cardiovascular and General Surgery
Zip code
Address
13-1 Takara-machi, Kanazawa-city, Ishikawa prefecture, Japan
TEL
076-265-2354
isa-mat@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Munehisa Takata |
Organization
Kanazawa University
Division name
Department of Thoracic Cardiovascular and General Surgery
Zip code
Address
13-1 Takara-machi, Kanazawa-city, Ishikawa prefecture, Japan
TEL
076-265-2354
Homepage URL
takatamunehisa0223@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
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
| 2016 | Year | 02 | Month | 29 | 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
| 2012 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2017 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024125
