UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036124 |
|---|---|
| Receipt number | R000041152 |
| Scientific Title | Potential of Automatic Diagnosis System with Image Enhanced Endoscopy for Diagnosis of Helicobacter. Pylori Infection |
| Date of disclosure of the study information | 2019/03/08 |
| Last modified on | 2019/03/08 01:07:36 |
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Basic information
Public title
Potential of Automatic Diagnosis System with Image Enhanced Endoscopy for Diagnosis of Helicobacter. Pylori Infection
Acronym
AI with LCI for diagnose HP infection
Scientific Title
Potential of Automatic Diagnosis System with Image Enhanced Endoscopy for Diagnosis of Helicobacter. Pylori Infection
Scientific Title:Acronym
AI with LCI for diagnose HP infection
Region
| Japan |
Condition
Condition
Chronic Gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is necessary to establish universal methods for endoscopic diagnosis of Helicobacter pylori (HP) infection, such as a computer-aided diagnosis. In this study, we propose a multistage diagnosis algorithm for HP infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The aims of this study are to construct a novel automatic diagnostic system for HP infection using a Support vector machine (SVM) .
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
we used five LCI images per case, which were taken from lesser curvature (angle-lower body and middle-upper body) and greater curvature (angle-lower body and middle-upper body) and fornix.
Key exclusion criteria
We excluded patients who were not checked H.p. infection by more than two examination or who have mucosal atrophy but did not have a history of H.p. eradication (thought to be spontaneous eradication) and who were not taken from all five view.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuda Takeshi |
Organization
Asahi University hospital
Division name
Gastroenterology
Zip code
Address
3-23, Hashimoto-cho Gifu city
TEL
058-253-8001
t-yasuda@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yagi Nobuaki |
Organization
Asahi University Hospital
Division name
Gastroenterology
Zip code
Address
3-23, Hashimoto-cho Gifu city
TEL
058-253-8001
Homepage URL
t-yasuda@koto.kpu-m.ac.jp
Sponsor or person
Institute
Asahi University Hospital
department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None.
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
Address
Tel
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
| 2019 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively analyzed patients who were checked H.p. infection by more than two different examinations and taken by LCI mode at Asahi University Hospital.were carried out using a LASEREO system (VP-4450 or -7000, and LL-4450 or -7000) and an upper gastrointestinal endoscope (EG-L590ZW or EG-L600ZW).
Management information
Registered date
| 2019 | Year | 03 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041152
