UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031770 |
|---|---|
| Receipt number | R000036269 |
| Scientific Title | Development of endoscopic surgery by using 8K super highvision technology |
| Date of disclosure of the study information | 2018/03/16 |
| Last modified on | 2018/05/01 15:57:55 |
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Basic information
Public title
Development of endoscopic surgery by using 8K super highvision technology
Acronym
Development of endoscopic surgery by using 8K super highvision technology
Scientific Title
Development of endoscopic surgery by using 8K super highvision technology
Scientific Title:Acronym
Development of endoscopic surgery by using 8K super highvision technology
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the usefulness and safety of laparoscopic surgery using 8K Super Hi-Vision camera
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Intraoperative and postoperative complications
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Laparoscopic 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
Colorectal cancer is proven by histopathological examination.
Preoperative examination reveal colon cancer or rectosigmoid cancer.
In blood test findings meet the prescribed conditions.
Key exclusion criteria
A case with cardiopulmonaly function is declining.
A pregnant woman.
A case with psychosis.
A case that is decided to be difficult to perticipate this trial.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihide Kanemitsu |
Organization
National Cancer Center Hospital
Division name
Division of Colorectal Surgery
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3547-5201
ykanemit@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Tsukamoto |
Organization
National Cancer Center Hospital
Division name
Division of Colorectal Surgery
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3547-5201
Homepage URL
shtsukam@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 16 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 16 | Day |
Last modified on
| 2018 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036269
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
