UMIN-CTR Clinical Trial

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
Email	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
Email	k2sakurai@marianna-u.ac.jp

Sponsor
Institute	Department of Neurolgy, St.Marianna University of medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042123