UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057369 |
|---|---|
| Receipt number | R000065535 |
| Scientific Title | Evaluation of the Effectiveness of Bronchoscopic Lung Volume Reduction (BLVR) in Severe COPD: A Prospective Exploratory Study |
| Date of disclosure of the study information | 2025/03/24 |
| Last modified on | 2025/03/25 19:33:40 |
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Basic information
Public title
Evaluation of the Effectiveness of Bronchoscopic Lung Volume Reduction (BLVR) in Severe COPD: A Prospective Exploratory Study
Acronym
Evaluation of the Effectiveness of Bronchoscopic Lung Volume Reduction (BLVR) in Severe COPD: A Prospective Exploratory Study
Scientific Title
Evaluation of the Effectiveness of Bronchoscopic Lung Volume Reduction (BLVR) in Severe COPD: A Prospective Exploratory Study
Scientific Title:Acronym
Evaluation of the Effectiveness of Bronchoscopic Lung Volume Reduction (BLVR) in Severe COPD: A Prospective Exploratory Study
Region
| Japan |
Condition
Condition
chronic obstructive lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An exploratory study on the multifaceted effects of bronchoscopic lung volume reduction (BLVR) in severe COPD, with a particular focus on its impact on physical activity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in physical activity levels
Improvement in pulmonary function test results
Improvement in anxiety and depression
Improvement in frailty and sarcopenia
Improvement in body composition
Evaluation of complications and incidence rate
Improvement in exercise tolerance and physical function
Improvement in subjective symptoms
Improvement in imaging assessment parameters
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with COPD scheduled for BLVR at our institution who meet the following criteria:
All treatment options outlined in the latest COPD diagnosis and treatment guidelines have been considered, and all feasible non-surgical treatments have been implemented (e.g., smoking cessation, inhalation therapy, pulmonary rehabilitation, etc.).
Sufficient respiratory function and overall condition to tolerate the invasiveness of the endoscopic procedure.
No blood coagulation disorders.
No allergies to the raw materials of the device.
Key exclusion criteria
Patients with musculoskeletal or neurological disorders that may affect physical activity levels.
Patients with progressive cancer.
Patients who meet contraindications for the 6-minute walk test.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka Municipal Hospital
Division name
Department of Respiratory Medicine
Zip code
515-0073
Address
1550 Tonomachi, Matsusaka 515-0073, Mie, Japan
TEL
0598231515
iwbd0524@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takemura |
Organization
Matsusaka Municipal Hospital
Division name
Department of Rehabilitation
Zip code
5150073
Address
1550 Tonomachi, Matsusaka 515-0073, Mie, Japan
TEL
0598231515
Homepage URL
pthiroyuki1988@gmail.com
Sponsor or person
Institute
Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
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
Matsusaka Municipal hospital
Address
1550 Tonomachi, Matsusaka 515-0073, Mie, Japan
Tel
0598231515
mchsakaguchi@city-hosp.matsusaka.mie.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 | 03 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular.
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065535
