UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038039 |
|---|---|
| Receipt number | 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 22:09:11 |
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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
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
mthrsgnm@chiba-u.jp
Sponsor or person
Institute
Respiratory medicine, Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043354
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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