UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051100 |
|---|---|
| Receipt number | R000058262 |
| Scientific Title | Development of a Gastrointestinal 3D Image Creation and Analysis System Using Gastrointestinal Endoscopy Images |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/05/18 17:56:29 |
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Basic information
Public title
Development of a three-dimensional imaging system for the gastrointestinal tract using endoscopic images
Acronym
Development of a three-dimensional imaging system for the gastrointestinal tract
Scientific Title
Development of a Gastrointestinal 3D Image Creation and Analysis System Using Gastrointestinal Endoscopy Images
Scientific Title:Acronym
Development of a 3D image creation and analysis system for the gastrointestinal tract
Region
| Japan |
Condition
Condition
Esophagus, Stomach, Colon
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Japanese people are highly susceptible to gastrointestinal cancer.
Currently, resection is considered the best way to cure gastrointestinal cancer.
Patients must undergo endoscopy, radiography, and computed tomography prior to treatment.
However, as the patient population ages, these tests are becoming a physical and financial burden for patients.
Therefore, we are developing a three-dimensional image construction system that replaces X-ray contrast examination based on the information obtained from endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences between 3D images of the gastrointestinal tract constructed from endoscopic images and conventional examinations (radiographic contrast and 3D CT examinations)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with gastrointestinal disorders and indications for gastrointestinal endoscopy
Key exclusion criteria
Under 20 years olds
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsumoto |
Organization
Kawasaki Medical school
Division name
Department of Gastroenterology
Zip code
7010192
Address
Matsushima 577, Kurashiki city, Okayama, Japan
TEL
81-86-462-1111
hmatsumoto0311@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsumoto |
Organization
Kawasaki Medical school
Division name
Department of Gastroenterology
Zip code
7010192
Address
Matsushima 577, Kurashiki city, Okayama, Japan
TEL
81-86-462-1111
Homepage URL
hmatsumoto0311@gmail.com
Sponsor or person
Institute
Kawasaki Medical school
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical school
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical school
Address
Matsushima 577, Kurashiki city, Okayama, Japan
Tel
81-86-462-1111
kenkyuhou2@med.kawasaki-m.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
| 2023 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Creating 3D images of the gastrointestinal tract from endoscopy videos
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058262
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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