UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040716 |
|---|---|
| Receipt number | R000046447 |
| Scientific Title | Assessment of localized pulmonary function by multiple pulmonary function test system in patients with respiratory disease |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2024/06/14 20:26:21 |
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Basic information
Public title
Assessment of localized pulmonary function by multiple pulmonary function test system in patients with respiratory disease
Acronym
multiple pulmonary function test system assessment
Scientific Title
Assessment of localized pulmonary function by multiple pulmonary function test system in patients with respiratory disease
Scientific Title:Acronym
multiple pulmonary function test system assessment
Region
| Japan |
Condition
Condition
airway stenosis, chronic obstructive pulmonary disease, bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To select the most suitable location for treatment during interventional bronchology
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Noted improvements in lateral pressure, ETO2, oxygen uptake, ETCO2, carbon dioxide discharge after treatment.
Key secondary outcomes
Correlations between lateral pressure, ETO2, oxygen uptake, ETCO2, carbon dioxide discharge and other study parameters.
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
Patients with airway stenosis, COPD and bronchial asthma able to undergo bronchoscopy.
Key exclusion criteria
Patients who can not safely undergo bronchoscopy due to unstable breathing
Target sample size
50
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, Depar tment 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, Depar tment 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
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, Japan 216-8511
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
| 2020 | Year | 06 | Month | 10 | 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
| 2020 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will measure oxygen and carbon dioxide concentration to estimate local pulmonary function during bronchoscopy. Further, we will investigate the efficacy of the multiple pulmonary function test system.
Management information
Registered date
| 2020 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046447
