UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063166 |
|---|---|
| Receipt number | R000072283 |
| Scientific Title | Feasibility Study of Pulse Wave-Like Signal Measurement in Healthy Adults Using an Ultrasound Sensor System |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/10/03 19:30:13 |
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Basic information
Public title
Feasibility Study of Pulse Wave-Like Signal Measurement in Healthy Adults Using an Ultrasound Sensor System
Acronym
Feasibility Study of Pulse Wave-Like Signal Measurement in Healthy Adults Using an Ultrasound Sensor System
Scientific Title
Feasibility Study of Pulse Wave-Like Signal Measurement in Healthy Adults Using an Ultrasound Sensor System
Scientific Title:Acronym
Feasibility Study of Pulse Wave-Like Signal Measurement in Healthy Adults Using an Ultrasound Sensor System
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This exploratory study will assess noninvasive pulse waveform acquisition using an ultrasound sensor system under development in healthy adults. At the radial artery, two-site PWV will be assessed at rest, during leg elevation, and during deep breathing, and compared with changes in systolic blood pressure. At rest, waveforms from both common carotid arteries will be acquired and compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of pulse waveform acquisition. For the radial artery, separate and simultaneous two-site acquisition will be evaluated at rest, after lower limb elevation, and after deep breathing. For the common carotid arteries, separate left- and right-side and bilateral acquisition will be evaluated at rest. Successful acquisition is defined as clear identification of the pulse upstroke and main peak without interference from signal saturation or motion artifacts.
Key secondary outcomes
Waveform acquisition stability; success rate of radial artery PWV calculation; directional agreement and correlation of changes between systolic blood pressure and PWV; and comparison of the morphological and temporal characteristics of the left and right common carotid artery waveforms at rest.
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
| Maneuver |
Interventions/Control_1
Several minutes of lower limb elevation/Several deep breaths
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) Individuals aged 18 years or older at the time of enrollment
(2) Individuals who self-report that they have not been diagnosed by a physician with hypertension, cardiovascular disease, cerebrovascular disease, or respiratory disease that may affect their ability to perform deep breathing
(3) Individuals who are able to perform deep breathing and lower limb elevation without assistance
(4) Individuals who have provided written informed consent to participate in the study
Key exclusion criteria
(1) Individuals with a resting systolic blood pressure of 140 mmHg or higher or a resting diastolic blood pressure of 90 mmHg or higher before the start of measurement
(2) Individuals with wounds, inflammation, infection, or other skin conditions on the forearm or neck where the sensors and fixation devices will be placed
(3) Individuals with an allergy to polyurethane gel or a history of itching or redness associated with the use of ultrasound gel
(4) Individuals who are pregnant or who self-report the possibility of pregnancy
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Haga |
Organization
Tohoku university
Division name
Biomedical Engineering
Zip code
980-8579
Address
6-6-12, Aoba, Aramaki, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-795-5250
haga@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Hayama |
Organization
Tohoku university
Division name
Biomedical Engineering
Zip code
980-8579
Address
6-6-12, Aoba, Aramaki, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-795-5251
Homepage URL
hayama.mayu.p7@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tohoku University
Address
2-1-1, Katahira, Aoba-ku, Sendai, Miyagi, Japan
Tel
N/A
tuhrp-soudan1@grp.tohoku.ac.jp
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
| 2026 | Year | 10 | Month | 05 | 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
| 2026 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072283
