UMIN-CTR Clinical Trial

Basic information
Public title	Epidemiology and CLInical Phenotype Study in the Emergency Department: ECLIPSE-ED study
Acronym	ECLIPSE-ED study
Scientific Title	Epidemiology and CLInical Phenotype Study in the Emergency Department: ECLIPSE-ED study
Scientific Title:Acronym	ECLIPSE-ED study
Region	Japan

Condition
Condition	All patients who visited the emergency department
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. Structuring and characterizing medical information from emergency departments
Basic objectives2	Others
Basic objectives -Others	2. To explore clinical phenotypes of emergency department patients, and then examine the effect of interventions performed at the emergency department. We also evaluate/predict clinical outcomes according to the clinical phenotypes.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Patient disposition (discharge, death)
Key secondary outcomes	2. Clinical diagnosis 3. In-hospital information including hospital length of stay 4. Interventions (e.g., surgical intervention)

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	120 years-old >
Gender	Male and Female
Key inclusion criteria	All patients who visited the emergency department
Key exclusion criteria	Patients who denied to participate this study
Target sample size	100000

Research contact person
Name of lead principal investigator	1st name Tadahiro Middle name Last name Goto
Organization	TXP Medical Co. Ltd.
Division name	TXP Research
Zip code	1138485
Address	7-3-1-252, Hongo, Bunkyo, Tokyo
TEL	0356158433
Email	tadahirogo.goto@txpmedical.com

Public contact
Name of contact person	1st name Tadahiro Middle name Last name Goto
Organization	TXP Medical Co. Ltd.
Division name	TXP Research
Zip code	1138485
Address	7-3-1-252, Hongo, Bunkyo, Tokyo
TEL	0356158433
Homepage URL
Email	tadahirogo.goto@txpmedical.com

Sponsor
Institute	TXP Medical Co. Ltd.
Institute
Department

Funding Source
Organization	TXP Medical Co.Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	TXP Medical Co.Ltd
Address	7-3-1-252, Hongo, Bunkyo, Tokyo
Tel	0356158433
Email	txp-ethics@txpmedical.com

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	2022 Year 04 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	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 16 Day
Date of IRB	2021 Year 07 Month 08 Day
Anticipated trial start date	2021 Year 07 Month 08 Day
Last follow-up date	2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We are recruiting participating hospitals

Management information
Registered date	2022 Year 03 Month 09 Day
Last modified on	2022 Year 03 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053756