UMIN-CTR Clinical Trial

Basic information
Public title	Performance Evaluation Test of Cuffless Blood Pressure Monitor Blood pressure measurement at rest and in motion Accuracy Verification Test
Acronym	Performance Evaluation Test of Cuffless Blood Pressure Monitor Blood pressure measurement at rest and in motion Accuracy Verification Test
Scientific Title	Performance Evaluation Test of Cuffless Blood Pressure Monitor Blood pressure measurement at rest and in motion Accuracy Verification Test
Scientific Title:Acronym	Performance Evaluation Test of Cuffless Blood Pressure Monitor Blood pressure measurement at rest and in motion Accuracy Verification Test
Region	Japan

Condition
Condition	none
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the test is to confirm the ethical validity and accuracy of the program based on the sensor information in the wearable device and to evaluate the ability of the program to accurately measure and calculate blood pressure values.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Deviation between blood pressure measured by aneroid sphygmomanometer and the device under study. Deviation between ABPM and blood pressure measured by the device under study.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Who have fully understood the purpose and content of this study and have given written consent 2. Male and Female 18 years of age or older
Key exclusion criteria	1. Those with evidence of chronic arrhythmia. 2. Who have uneven skin or dark skin such as black spots on the wrists due to wounds, burns, etc. 3. Who have a limb defect or a shunt in the left upper limb. 4. Who have difficulty in wearing the wearable device used in this evaluation test. (Minimum forearm circumference is less than 130 mm or more than 195 mm) 5. at Rest (1) Those whose upper arm does not fit the cuff size for aneroid sphygmomanometer. (Those whose upper arm circumference is 200 mm or less or whose upper arm circumference is 420 mm or more) 6. in Motion (1) Those whose upper arm does not conform to the cuff size for ABPM. (Those whose upper arm circumference is less than 200mm or more than 420mm.) (2)Those who cannot perform walking movements using a treadmill at a speed of 1.5 km to 3 km per hour.
Target sample size	1050

Research contact person
Name of lead principal investigator	1st name Aki Middle name Last name Tsuji
Organization	TOKYO CENTER CLINIC
Division name	Clinical Research Group
Zip code	103-0028
Address	Yaesu KT Building 2F, 1-1-8, Yaesu, Chuo-ku, Tokyo
TEL	03-3276-6935
Email	tccv@tc-clinic.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Watabe
Organization	TOKYO CENTER CLINIC
Division name	Clinical Research Group
Zip code	103-0028
Address	Yaesu KT Building 2F, 1-1-8, Yaesu, Chuo-ku, Tokyo
TEL	03-3276-6935
Homepage URL
Email	watabe@tc-clinic.jp

Sponsor
Institute	TOKYO CENTER CLINIC
Institute
Department

Funding Source
Organization	Arblet Inc.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Non Profit Organization Tokyo Allergy and Respiratory Disease Research Institute
Address	River Side Kuramae 3F, 1-8-6, Kuramae, Taito-ku, Tokyo
Tel	080-7360-0910
Email	info@inclusion-p.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	東京センタークリニック（東京都） TOKYO CENTER CLINIC (TOKYO)

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 04 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	Completed
Date of protocol fixation	2022 Year 05 Month 24 Day
Date of IRB	2022 Year 05 Month 25 Day
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 06 Month 04 Day
Last modified on	2022 Year 08 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054661