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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028138
Receipt No. R000032209
Scientific Title Research on development of a new wearable arterial pulse wave detection device
Date of disclosure of the study information 2017/07/07
Last modified on 2017/07/07

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Basic information
Public title Research on development of a new wearable arterial pulse wave detection device
Acronym development of a wearable pulse wave detection device
Scientific Title Research on development of a new wearable arterial pulse wave detection device
Scientific Title:Acronym 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
1st name
Middle name
Last name TOSHIFUMI KUDO
Organization Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name Vascular Surgery
Zip code
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
1st name
Middle name
Last name TOSHIFUMI KUDO
Organization Tokyo Medical and Dental University
Division name Vascular Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 08 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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