UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027634 |
|---|---|
| Receipt number | R000031660 |
| Scientific Title | A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound |
| Date of disclosure of the study information | 2017/06/04 |
| Last modified on | 2020/03/19 16:24:59 |
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Basic information
Public title
A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound
Acronym
A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound
Scientific Title
A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound
Scientific Title:Acronym
A feasibility study on whether a stethoscope sensor using a sheet type biosensor can record heart murmur and heart sound
Region
| Japan |
Condition
Condition
hospitalized patient and outpatient
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate whether the auscultation sensor can appropriately record vibrations such as heart murmurs and heart sounds
Basic objectives2
Others
Basic objectives -Others
feasibility study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate whether the auscultation sensor can appropriately record vibrations such as heart murmurs and heart sounds
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
a stethoscope sensor
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who got written consent
Key exclusion criteria
Patients that researchers deemed inappropriate as subjects
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Umemoto |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519
TEL
03-5803-5231
umemoto.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Umemoto |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519
TEL
03-5803-5231
Homepage URL
umemoto.cvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Yamaha Corporation
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
Medical Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519
Tel
03-5803-5096
info.bec@tmd.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
| 2017 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031660
