UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013085 |
|---|---|
| Receipt number | R000015269 |
| Scientific Title | Development of automatic diagnosis system for the visible region in the capsule endoscopy |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2024/08/13 18:20:01 |
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Basic information
Public title
Development of automatic diagnosis system for the visible region in the capsule endoscopy
Acronym
Development of automatic diagnosis system for the capsule endoscopy
Scientific Title
Development of automatic diagnosis system for the visible region in the capsule endoscopy
Scientific Title:Acronym
Development of automatic diagnosis system for the capsule endoscopy
Region
| Japan |
Condition
Condition
Small bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on automatically quantifying system for the visibility of the capsule endoscope image.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Confidence of the visible area which determined by image analysis software and the endscopist in the capsule endoscope image.
Key secondary outcomes
none
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It does not matter age or gender.
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Hashimoto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2241
has-333@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Hashimoto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2241
Homepage URL
has-333@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research. Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, Japan
Tel
0836-22-2428
me223@yamaguchi-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
山口大学医学部付属病院（山口県）、山口大学工学部
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 31 | 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
| 2013 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 30 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2014 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015269
