UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028890 |
|---|---|
| Receipt number | R000033048 |
| Scientific Title | examination of volume of saline solution used by bronchoalveolar lavage with balloon catheter |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/11/12 13:06:17 |
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Basic information
Public title
examination of volume of saline solution used by bronchoalveolar lavage with balloon catheter
Acronym
balloon BAL
Scientific Title
examination of volume of saline solution used by bronchoalveolar lavage with balloon catheter
Scientific Title:Acronym
balloon BAL
Region
| Japan |
Condition
Condition
diffuse lung disease to scheduled for bronchoalveolar lavage
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
examination of volume of saline solution used by bronchoalveolar lavage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
examination of volume of saline solution used by bronchoalveolar lavage
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
bronchoalveolar lavage
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) Sarcoidosis, Organized pneumonia, Eosinophilic pneumonia or hypersensitivity pneumonitis are suspected. Suspected idiopathic pulmonary fibrosis with typical imaging findings.
2) Diffuse lung disease scheduled to undergo surgical lung biopsy.
3) Bronchoscopy consent has been obtained.
4) Transbronchial lung biopsy can also be performed at the same time.
5) Consent has been obtained in writing by the person himself about research participation.
Key exclusion criteria
1) Combined blood disorders that show abnormalities in white blood cell fraction.
2) Receiving treatment with steroids.
3) Receiving treatment with immunosuppressive drugs.
4) Receiving treatment with biological preparation
5) Receiving treatment with antineoplastic agent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Hotta |
Organization
Shimane University, School of Medicine
Division name
Clinical Oncology and Respiratory Medicine, Department of Internal Medicine
Zip code
6938501
Address
89-1, Enya-cho,Izumo-shi,Shimane.
TEL
0853-20-2580
takamasa@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Hotta |
Organization
Shimane University, School of Medicine
Division name
Clinical Oncology and Respiratory Medicine, Department of Internal Medicine
Zip code
6938501
Address
89-1, Enya-cho,Izumo-shi,Shimane.
TEL
0853-20-2580
Homepage URL
takamasa@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University, School of 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
Shimane University, School of Medicine
Address
89-1, Enya-cho,Izumo-shi,Shimane.
Tel
0853-20-2580
takamasa@med.shimane-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
| 2017 | Year | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033048
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
