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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038039
Receipt No. R000043354
Scientific Title Efficiency and safety of bronchoalveolar lavage with balloon catheter -pilot study to evaluate safety-
Date of disclosure of the study information 2019/10/01
Last modified on 2020/11/13

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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

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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