UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015315 |
|---|---|
| Receipt number | R000017813 |
| Scientific Title | Clinical study of Robot-assisted surgery using da Vinci Surgical System for mediastinal tumors |
| Date of disclosure of the study information | 2014/10/02 |
| Last modified on | 2019/10/07 15:49:20 |
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Basic information
Public title
Clinical study of Robot-assisted surgery using da Vinci Surgical System for mediastinal tumors
Acronym
Clinical study of Robot-assisted surgery for mediastinal tumors
Scientific Title
Clinical study of Robot-assisted surgery using da Vinci Surgical System for mediastinal tumors
Scientific Title:Acronym
Clinical study of Robot-assisted surgery for mediastinal tumors
Region
| Japan |
Condition
Condition
mediastinal diseases
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the usability and safety of endoscopic surgery using da Vinci Surgical System for mediastinal diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
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 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A case that an operation under the general anesthesia is possible.
A case that a document agrrement by the examination participation.
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Hokka |
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, Japan, 81
TEL
078-382-5750
dhokka@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Hokka |
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, Japan, 81
TEL
078-382-5750
Homepage URL
dhokka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Kobe, Japan
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 02 | Day |
Last modified on
| 2019 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017813
