UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036977 |
|---|---|
| Receipt number | R000042123 |
| Scientific Title | Research on development of diagnosis assistance application OneStroke for stroke |
| Date of disclosure of the study information | 2019/06/10 |
| Last modified on | 2019/06/10 11:43:43 |
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Basic information
Public title
Research on development of diagnosis assistance application OneStroke for stroke
Acronym
Research on development of diagnosis assistance application OneStroke for stroke
Scientific Title
Research on development of diagnosis assistance application OneStroke for stroke
Scientific Title:Acronym
Research on development of diagnosis assistance application OneStroke for stroke
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an application, OneStroke, for assisting non-stroke specialists in the initial treatment of acute ischemic stroke
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of medical diagnostic application, OneStroke, for cerebral infarction and development of a tool with automatic reading function using artificial intelligence for brain CT image of cerebral infarction, and confirm its effeffecaly and safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The developed device(application for medical assistance and tool of CT automatic interpretation) will be utilized at the emergency room in 50 patients hospitalized for cerebral infarction.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) In principle, patients at the age of 20 years or older at the time of obtaining consent (in the case of minors, consent of legal guardian is required)
(2) Patients whose self-intention document consent has been obtained
Key exclusion criteria
(1) Patients judged to be in a serious condition requiring a super emergency by medical examination
(2) Patients who could not obtain written consent by their own intention (in the case of minors, legal guardians)
(3) Other patients judged to be inappropriate as subjects by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenzo |
| Middle name | |
| Last name | Sakurai |
Organization
St.Marianna University of medicine
Division name
Neurology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa-ken, Japan
TEL
044-977-8111
k2sakurai@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenzo |
| Middle name | |
| Last name | Sakurai |
Organization
St.Marianna University of medicine
Division name
Neurology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa-ken, Japan
TEL
044-977-8111
Homepage URL
k2sakurai@marianna-u.ac.jp
Sponsor or person
Institute
Department of Neurolgy,
St.Marianna University of medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marianna University of medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa-ken, Japan
Tel
044-977-8111
k2sakurai@marianna-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
| 2019 | Year | 06 | Month | 10 | 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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 05 | Day |
Last modified on
| 2019 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042123
