UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052700 |
|---|---|
| Receipt number | R000060137 |
| Scientific Title | Assessment of gas exchange at the targeted and residual lobes by multiple pulmonary function test system during bronchoscopic lung volume reduction |
| Date of disclosure of the study information | 2023/11/06 |
| Last modified on | 2025/05/22 22:27:21 |
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Basic information
Public title
Assessment of gas exchange by multiple pulmonary function test system during bronchoscopic lung volume reduction
Acronym
Bronchoscopic lung volume reduction assessment by multiple pulmonary function test system
Scientific Title
Assessment of gas exchange at the targeted and residual lobes by multiple pulmonary function test system during bronchoscopic lung volume reduction
Scientific Title:Acronym
Bronchoscopic lung volume reduction assessment by multiple pulmonary function test system
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess gas exchange at the targeted and residual lobes during bronchoscopic lung volume reduction procedures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of gas exchange at targeted and residual lobes by ETO2, oxygen uptake, ETCO2, and carbon dioxide discharge during bronchoscopic lung volume reduction procedures.
Key secondary outcomes
Correlations between 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
1. Men and women over 20 years old.
2. Patients with COPD.
3. Ex-smokers.
4. Patients who agreed to participate in this study with written informed consent.
Key exclusion criteria
1. Post-bronchodilator FEV1 below 15% and over 45% predicted value.
2. Total lung capacity less than 100% predicted value.
3. Residual volume less than 175% predicted value.
4. Carbon monoxide diffusing capacity of less than 20% of the predicted value.
5. Unstable cardiac conditions.
6. Presence of giant bullae.
7. Active infection.
8. Patients who can not safely undergo bronchoscopy due to unstable breathing.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Mineshita |
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
m-mine@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
Profit organization
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
| 2023 | Year | 11 | Month | 06 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | 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 concentrations at targeted and residual lobes to estimate gas exchange by multiple pulmonary function test system during bronchoscopic lung volume reduction procedure.
Management information
Registered date
| 2023 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060137
