UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003904 |
|---|---|
| Receipt number | R000004488 |
| Scientific Title | Transbronchial Decompression of Emphysematous bullae |
| Date of disclosure of the study information | 2010/07/13 |
| Last modified on | 2018/07/18 10:58:56 |
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Basic information
Public title
Transbronchial Decompression of Emphysematous bullae
Acronym
Decompression of Emphysematous bullae
Scientific Title
Transbronchial Decompression of Emphysematous bullae
Scientific Title:Acronym
Decompression of Emphysematous bullae
Region
| Japan |
Condition
Condition
emphysematous bullae, emphysema
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and safety of transbronchial decompression of emphysematous bullae
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary Function Tests
Key secondary outcomes
MRC dyspnea grade, QOL, CT findings, cardiac function, exercise performance, adverse events.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transbronchial needle aspiration of emphysematous bullae
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Literate patients able to understand and sign the Informed Consent Form.
2.FEV1 < 50% of predicted value
3.MRC grade > 1
4.Emphysematous bullae accessible by needle aspiration.
5. Patient that are considered unfit for lung volume reduction surgery or bullectomy by a thoracic surgeon.
Key exclusion criteria
1.Unstable cardiac disease
2.Hypoxia during bronchoscopy under oxygen supplement
3.Patients designated as inappropriate for this study by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamichi Mineshita |
Organization
St.Marianna University School of Medicine
Division name
Division of respiratory and infectiousdiseases
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa, Japan
TEL
044-977-8111
m-mine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masamichi Mineshita |
Organization
St.Marianna University School of Medicine
Division name
Division of respiratory and infectiousdiseases
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa
TEL
044-977-8111
Homepage URL
m-mine@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine. Division of respiratory and infectiousdiseases
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 07 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 12 | Day |
Last modified on
| 2018 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004488
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
