UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019756 |
|---|---|
| Receipt number | R000022009 |
| Scientific Title | Feasibility study of endoscopic all-in-focus image creation and analysis in the gastrointestinal tract. |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2019/11/15 16:12:14 |
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Basic information
Public title
Feasibility study of endoscopic all-in-focus image creation and analysis in the gastrointestinal tract.
Acronym
Feasibility study of endoscopic all-in-focus image creation and analysis in the gastrointestinal tract.
Scientific Title
Feasibility study of endoscopic all-in-focus image creation and analysis in the gastrointestinal tract.
Scientific Title:Acronym
Feasibility study of endoscopic all-in-focus image creation and analysis in the gastrointestinal tract.
Region
| Japan |
Condition
Condition
intestinal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Improvement of the endoscope diagnosis ability for the gastrointestinal tract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Consistency with all-in-focus image and pathology organizations of excision specimen
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In a case already had a gastrointestinal lesion pointed out, and to take careful inspections by endoscope and the case that an operation or the endoscope treatment is planned in future.
The case that it was obtained its consent for endoscope observation in 20 years old or more.
Key exclusion criteria
The case that was not obtained consent for a study.
The case that was taken as inappropriateness as a subject.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endoscopy
Zip code
466-0065
Address
65, Tsuruma-cho Showa-ku, Nagoya, 466-8550 Japan.
TEL
052-744-2431
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Matsui |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-0065
Address
65, Tsuruma-cho Showa-ku, Nagoya, 466-8550 Japan.
TEL
052-744-2431
Homepage URL
k-matsui@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine.
Department of Gastroenterology and Hepatology.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meijo University Department of Mechatronics Engineering
Osaka University Graduate School of Engineering Science.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Life ethics screening committee
Address
65, Tsuruma-cho Showa-ku, Nagoya, 466-8550 Japan.
Tel
052-744-2431
ethics@med.nagoya-u.ac.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
| 2015 | Year | 11 | Month | 11 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Consistency with aii-in-focus image and pathology of excision specimen.
The patient who met criteria for selection from Nov.2015 to Nov.2016.
Management information
Registered date
| 2015 | Year | 11 | Month | 11 | Day |
Last modified on
| 2019 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022009
