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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028890
Receipt No. 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 2018/08/30

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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
Middle name
Last name Takamasa Hotta
Organization Shimane University, School of Medicine
Division name Clinical Oncology and Respiratory Medicine, Department of Internal Medicine
Zip code
Address 89-1, Enya-cho,Izumo-shi,Shimane.
TEL 0853-20-2580
Email takamasa@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamasa Hotta
Organization Shimane University, School of Medicine
Division name Clinical Oncology and Respiratory Medicine, Department of Internal Medicine
Zip code
Address 89-1, Enya-cho,Izumo-shi,Shimane.
TEL 0853-20-2580
Homepage URL
Email takamasa@med.shimane-u.ac.jp

Sponsor
Institute Shimane University, School of Medicine
Institute
Department

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
Address
Tel
Email

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
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.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


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