UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	New device for nurses to detect patients leave from bed
Title of the study (Brief title)	New sensor to detect patients leave from bed
Region	Japan

Condition
Condition	all diseases
Classification by specialty	Medicine in general Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of new sensor device to protect patients falling down
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Harmful events
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	3 days; randomaized order
Interventions/Control_2	3 days; randomaized order
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	agreeable
Key exclusion criteria	none
Target sample size	30

Research contact person
Name of lead principal investigator	Homma Satoshi
Organization	Univ of Tsukuba
Division name	Risk management
Address	1-1-1 tennnodai, Tsukuba City
TEL	029-853-5785
Email	shonma-circ@umin.ac.jp

Public contact
Name of contact person	Yoshihito Nakano
Organization	Univ of Tsukuba
Division name	Risk management
Address	1-1-1 tennnodai, Tsukuba City
TEL	029-853-5785
Homepage URL
Email	homma-s@md.tsukuba.ac.jp

Sponsor
Institute	Univ of Tsukuba
Institute
Department

Funding Source
Organization	Univ of Tsukuba
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 20 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 24 Day
Last modified on	2017 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033937