UMIN-CTR Clinical Trial

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
Email	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
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	Shimane University, School of Medicine
Address	89-1, Enya-cho,Izumo-shi,Shimane.
Tel	0853-20-2580
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033048