UMIN-CTR Clinical Trial

Basic information
Public title	Efficiency and safety of bronchoalveolar lavage with balloon catheter -pilot study to evaluate safety-
Acronym	bronchoalveolar lavage with balloon catheter
Scientific Title	Efficiency and safety of bronchoalveolar lavage with balloon catheter -pilot study to evaluate safety-
Scientific Title:Acronym	bronchoalveolar lavage with balloon catheter
Region	Japan

Condition
Condition	Diffuse lung disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of bronchoalveolar lavage with a balloon catheter in a pilot study.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	All serious adverse events
Key secondary outcomes	1 Insufficient recovery of BALF (recovery rate less than 30%) 2 Onset of all test complications occurring within one month after BAL procedure 3 Procedure time (time from fiber insertion to end of bronchoalveolar lavage) 4 Recovery rate of bronchoalveolar lavage fluid (recovery volume / injection volume x 100%)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	A balloon catheter is used when performing bronchoalveolar lavage. Intervention is only during BAL procedure.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Patients suspected of diffuse lung disease (2) Patients who are 20 years old or older and under 80 years old at the time of consent (3) Patients who have obtained consent for bronchoscopy (4) Patients who have received sufficient explanation about the contents of this study and have obtained written consent
Key exclusion criteria	(1) Patients undergoing treatment for diffuse lung disease including steroids and immunosuppressants (2) Patients with malignant tumors that have not been cured (3) Patients with allergy to natural rubber (4) Patients with SpO2 at rest of less than 95% (5) Other patients who are judged to be ineligible by the attending physician
Target sample size	12

Research contact person
Name of lead principal investigator	1st name MITSUHIRO Middle name Last name ABE
Organization	Chiba University Hospital
Division name	Respiratory medicine
Zip code	260-8677
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
TEL	0432227171
Email	mthrsgnm@chiba-u.jp

Public contact
Name of contact person	1st name MITSUHIRO Middle name ABE Last name ABE
Organization	Chiba University Hospital
Division name	Respiratory medicine
Zip code	260-8677
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
TEL	0432227171
Homepage URL
Email	mthrsgnm@chiba-u.jp

Sponsor
Institute	Respiratory medicine, Chiba University Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University Hospital
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
Tel	043-222-7171
Email	mthrsgnm@chiba-u.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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2019 Year 10 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	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 09 Month 17 Day
Anticipated trial start date	2019 Year 10 Month 30 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 18 Day
Last modified on	2020 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043354