UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048944 |
|---|---|
| Receipt number | R000055751 |
| Scientific Title | Experimental verification of real-time information assisted surgery through pathological examination: a single center, prospective observational study |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2022/09/26 18:49:39 |
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Basic information
Public title
Experimental verification of real-time information assisted surgery through pathological examination: a single center, prospective observational study
Acronym
Experimental verification of information assisted surgery through pathological examination
Scientific Title
Experimental verification of real-time information assisted surgery through pathological examination: a single center, prospective observational study
Scientific Title:Acronym
Experimental verification of information assisted surgery through pathological examination
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To conduct pathological verification of deep learning model for the semantic segmentation of autonomic nerves during laparoscopic colorectal surgery
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A pathological examination was conducted whether or not the model outputs were nerve.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients underwent laparoscopic sigmoid or rectal surgeries at the Department of Colorectal Surgery of the National Cancer Center Hospital East, Chiba, Japan
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Itou |
Organization
National Cancer Center Hospital East
Division name
Surgical Device Innovation Office
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
TEL
0471-33-1111
maito@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Kitaguchi |
Organization
National Cancer Center Hospital East
Division name
Surgical Device Innovation Office
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
TEL
0471-33-1111
Homepage URL
dkitaguc@east.ncc.go.jp
Sponsor or person
Institute
Surgical Device Innovation Office, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Institutional Review Board, National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
Tel
0471-33-1111
irst@ml.res.ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 26 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Project No. 2020-315
Title: Analytical research on surgical information using a database of surgical videos of endoscopic surgeries
Research Project No. 2020-269
Title: Experimental verification of real-time information assisted surgery through pathological examination: a single center, prospective observational study
Management information
Registered date
| 2022 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055751
