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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019756
Receipt No. 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

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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
Email 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
Email k-matsui@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine.
Department of Gastroenterology and Hepatology.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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