UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038941 |
|---|---|
| Receipt number | R000044384 |
| Scientific Title | Implimentation of robotic assisted thoracoscopic surgery for benign mediastinal tumor |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2020/03/27 12:47:49 |
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Basic information
Public title
Implimentation of robotic assisted thoracoscopic surgery for benign mediastinal tumor
Acronym
Implimentation of robotic assisted thoracoscopic surgery for benign mediastinal tumor
Scientific Title
Implimentation of robotic assisted thoracoscopic surgery for benign mediastinal tumor
Scientific Title:Acronym
Implimentation of robotic assisted thoracoscopic surgery for benign mediastinal tumor
Region
| Japan |
Condition
Condition
benign mediastinal tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Implimentation of robotic assisted thoracoscopic surgery for benign mediastinal tumor
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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
Operation
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient of benign mediastinal tumor
Key exclusion criteria
none
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Inoue |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Thoracic Surgery
Zip code
230-8765
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
TEL
045-576-3000
yo_inoue@tobu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Inoue |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Thoracic Surgery
Zip code
230-8765
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
TEL
045-576-3000
Homepage URL
yo_inoue@tobu.saiseikai.or.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Surgery, Saiseikai Yokohamashi Tobu Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Tobu Hospital
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
Tel
045-576-3000
yo_inoue@tobu.saiseikai.or.jp
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
済生会横浜市東部病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2019 | Year | 12 | Month | 20 | Day |
Last modified on
| 2020 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044384
