UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051168 |
|---|---|
| Receipt number | R000058357 |
| Scientific Title | Observational study on the development of a breath sound analysis system as a medical support tool for interstitial pneumonia |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/05/25 21:39:48 |
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Basic information
Public title
Observational study on the development of a breath sound analysis system as a medical support tool for interstitial pneumonia
Acronym
Analysis of auscultatory sounds in interstitial pneumonia
Scientific Title
Observational study on the development of a breath sound analysis system as a medical support tool for interstitial pneumonia
Scientific Title:Acronym
Analysis of auscultatory sounds in interstitial pneumonia
Region
| Japan |
Condition
Condition
Interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By displaying the waveforms of lung sounds recorded with an electronic stethoscope and the analysis results on a PC, we are developing lung sound analysis software with a diagnostic support function that is not easily affected by the auscultation skill level of medical personnel.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Decision threshold for lung sound analysis in assisting diagnosis of interstitial pneumonia.
Key secondary outcomes
Relationship between the severity of imaging and lung sound analysis in interstitial pneumonia
Relationship between clinical diagnosis of interstitial pneumonia and lung sound analysis
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria and have already been clinically diagnosed with interstitial pneumonia.
Abnormal breath sounds are heard on auscultation with a conventional stethoscope.
High-resolution CT (HRCT) scan by two or more respiratory specialists or radiologists shows interstitial pneumonia.
Elevation of pulmonary fibrosis markers such as KL-6 and SP-D
Key exclusion criteria
Patients thought to be complicated by active respiratory tract infection
Patients in which auscultation is difficult (e.g., severe cough, difficulty with deep inspiration, difficulty restraining oneself during auscultation)
Patients with life-threatening conditions such as respiratory or cardiac failure requiring emergency treatment
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Matsunaga |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Respiratory and Infectious Diseases
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube City, Yamaguchi Prefecture
TEL
0836853123
noyamama@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Asami-Noyama |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Respiratory and Infectious Diseases
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube City, Yamaguchi Prefecture
TEL
09062166020
Homepage URL
noyamama@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
MAKI Asami-Noyama
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for clinical research. Yamaguchi University Hospital.
Address
1-1-1 Minami-kogushi
Tel
0836-22-2428
me223@yamaguchi-u.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
| 2024 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing to report.
Management information
Registered date
| 2023 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058357
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
