UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047950 |
|---|---|
| Receipt number | R000054665 |
| Scientific Title | Performance Evaluation Test of Cuffless Sphygmomanometer Blood pressure measurement at rest and in motion Performance evaluation test |
| Date of disclosure of the study information | 2022/07/23 |
| Last modified on | 2022/08/29 10:34:27 |
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Basic information
Public title
Performance Evaluation Test of Cuffless Sphygmomanometer
Blood pressure measurement at rest and in motion
Performance evaluation test
Acronym
Performance Evaluation Test of Cuffless Sphygmomanometer
Blood pressure measurement at rest and in motion
Performance evaluation test
Scientific Title
Performance Evaluation Test of Cuffless Sphygmomanometer
Blood pressure measurement at rest and in motion
Performance evaluation test
Scientific Title:Acronym
Performance Evaluation Test of Cuffless Sphygmomanometer
Blood pressure measurement at rest and in motion
Performance evaluation 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 evaluate the ability of the program to accurately measure and calculate blood pressure values based on the sensor information in the wearable device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
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 310mm.)
(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
150
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
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
watabe@tc-clinic.jp
Sponsor or person
Institute
TOKYO CENTER CLINIC
Institute
Department
Personal name
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
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 | 07 | Month | 23 | 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 | 05 | Day |
Last modified on
| 2022 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054665
