UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on development of a new wearable arterial pulse wave detection device
Title of the study (Brief title)	development of a wearable pulse wave detection device
Region	Japan

Condition
Condition	peripheral arterial disease
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For the prevention or early detection of arteriosclerotic lesions of the whole body, we aim to develop a simple and noninvasive new wrist-worn (portable) pulse wave detection device.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reproducibility of test data by newly developed pulse wave detection device and correlation with existing blood pressure pulse wave inspection device
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Using the newly developed pulse wave detection sensor, the pulse wave of the subject is measured at the wrist joint site
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients falling under all the following conditions are targeted. 1) Male and female aged 18 or older at the time of acquiring consent 2) After receiving sufficient explanation for the participation of this study, after having sufficient understanding, the patient or the healthy person who gained document consent by the patient's free will
Key exclusion criteria	Those that fall under any of the following conditions are not considered. 1) At the time of obtaining consent, the age is under 18 2) Patients with severe heart disease or who are in shock (systolic blood pressure less than 90 mmHg) 3) Patients who have severe respiratory illness and require oxygen inhalation or ventilator management 4) Patients with severe liver disease (AST (GOT) or ALT (GTP)> 100 U) 5) Women who may be pregnant or have a possibility of pregnancy 6) Women who are breastfeeding 7) Difficult cases of self-determination right (dementia, consciousness disturbance, etc.) 8) Patients judged unsuitable as research subjects by Research doctors
Target sample size	100

Research contact person
Name of lead principal investigator	TOSHIFUMI KUDO
Organization	Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name	Vascular Surgery
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5261
Email	t-kudo.srg1@tmd.ac.jp

Public contact
Name of contact person	TOSHIFUMI KUDO
Organization	Tokyo Medical and Dental University
Division name	Vascular Surgery
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5261
Homepage URL
Email	t-kudo.srg1@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	YAMAHA
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 07 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 07 Month 07 Day
Last modified on	2017 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032209