UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056784 |
|---|---|
| Receipt number | R000064904 |
| Scientific Title | Detection of persistent pulmonary air leaks during balloon occlusion test using the multiple pulmonary function measurement system |
| Date of disclosure of the study information | 2025/01/22 |
| Last modified on | 2026/02/01 12:05:55 |
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Basic information
Public title
Detection of persistent pulmonary air leaks during balloon occlusion test using the multiple pulmonary function measurement system
Acronym
Air leak detection by multiple pulmonary function measurement system
Scientific Title
Detection of persistent pulmonary air leaks during balloon occlusion test using the multiple pulmonary function measurement system
Scientific Title:Acronym
Air leak detection by multiple pulmonary function measurement system
Region
| Japan |
Condition
Condition
persistent pulmonary air leaks, pneumothorax
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the affected bronchi of persistent pulmonary air leaks by measuring airway pressure at the site of obstruction during balloon occlusion test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the affected bronchi of persistent pulmonary air leaks by comparing airway pressure at the site of obstruction and pleural pressure.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patients with persistent pulmonary air leaks able to undergo bronchial occlusion.
2. Patients who agreed to participate in this study with written informed consent.
Key exclusion criteria
Patients who cannot safely undergo bronchoscopy due to unstable breathing.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nishine |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao Miyamae-ku Kawasaki, Japan
TEL
044-977-8111
h2nishine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nishine |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao Miyamae-ku Kawasaki, Japan
TEL
044-977-8111
Homepage URL
h2nishine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Hiroki Nishine
Funding Source
Organization
COSMOSWEB Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
Tel
044-977-8111
h2nishine@marianna-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
| 2025 | Year | 01 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will verify whether measuring airway pressure at the site of obstruction during balloon occlusion test improves the accuracy of identifying the affected bronchi.
Management information
Registered date
| 2025 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064904
