UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016372 |
|---|---|
| Receipt number | R000018842 |
| Scientific Title | Examination of the utility of pulmonary sound separation analysis in respiratory diseases |
| Date of disclosure of the study information | 2015/01/29 |
| Last modified on | 2015/01/29 13:57:41 |
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Basic information
Public title
Examination of the utility of pulmonary sound separation analysis in respiratory diseases
Acronym
Examination of the utility of pulmonary sound separation analysis in respiratory diseases
Scientific Title
Examination of the utility of pulmonary sound separation analysis in respiratory diseases
Scientific Title:Acronym
Examination of the utility of pulmonary sound separation analysis in respiratory diseases
Region
| Japan |
Condition
Condition
respiratory disease
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The discriminability (sensitivity, specificity) of the pulmonary sound analysis factors ( frequency, pulmonary sound component) which are provided from the recorded pulmonary sound by the new lung sound signal separation technique is examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The discriminability of the pulmonary sound analysis factors which are provided from the recorded pulmonary sound by the new lung sound signal separation technique.
Key secondary outcomes
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
1. 20 years or older.
2. The patient with written informed consent after the understanding all the study explanation.
Key exclusion criteria
Any of the follows:
1. The person who lacks of the ability of the agreement.
2. A person under 20 years old.
3. Insufficient understanding.
4. Medical student of Nagasaki University, A medical intern of Nagasaki University Hospital, Employee of the drug industry.
5.The patients who the principal investigator judged as inappropriate.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Tomonaga |
Organization
Nagasaki University Hospital
Division name
Second department of internal medicine
Zip code
Address
1-7-1 Sakamoto , Nagasaki
TEL
095-819-7273
ninai@ml.nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaomi Tomonaga |
Organization
Nagasaki University Hospital
Division name
Second department of internal medicine
Zip code
Address
1-7-1 Sakamoto , Nagasaki
TEL
095-819-7273
Homepage URL
ninai@ml.nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital Second department of internal medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 29 | 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
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective study that the discriminability (sensitivity, specificity) of the pulmonary sound analysis factors which are provided from the recorded pulmonary sound by the lung sound signal separation technique is examined.
Management information
Registered date
| 2015 | Year | 01 | Month | 29 | Day |
Last modified on
| 2015 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018842
