UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001310 |
|---|---|
| Receipt number | R000001588 |
| Scientific Title | An open-label prospective trial designed to evaluate the safety and efficacy of bronchoscopic lung volume reduction (BLVR) by autologous blood injection in emphysematous lung diseases |
| Date of disclosure of the study information | 2008/08/11 |
| Last modified on | 2009/12/22 02:24:57 |
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Basic information
Public title
An open-label prospective trial designed to evaluate the safety and efficacy of bronchoscopic lung volume reduction (BLVR) by autologous blood injection in emphysematous lung diseases
Acronym
BLVR by Injecting Bioactive agent and Autologous blood (BIBA)
Scientific Title
An open-label prospective trial designed to evaluate the safety and efficacy of bronchoscopic lung volume reduction (BLVR) by autologous blood injection in emphysematous lung diseases
Scientific Title:Acronym
BLVR by Injecting Bioactive agent and Autologous blood (BIBA)
Region
| Japan |
Condition
Condition
Emphysematous lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical efficacy of novel bronchoscopic lung volume reduction (BLVR) by autologous blood injection in emphysematous lung diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events/ Changes of symptomatic relief assessed by dyspnea scale/ Changes of pulmonary physiological parameters
Key secondary outcomes
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 autologous blood injection
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with emphysematous lung disease, showing dyspnea on exertion (Medical Research Council: more than Grade 3) despite of optical medical therapy more than for 3 months.
2) CT showing eligible heterogeneous emphysema.
3) Pulmonary function test showing obstructive pattern and air-trapping.
4) Good major organ fnction.
5) Written informed consent.
Key exclusion criteria
1) Evidence of active infection.
2) Evidence of systemic diseases or neoplasia expected to compromise survival during 5-yr period.
3) Any disease or condition that interferes with completion of initial or follow-up assessments.
4) Patients who are judged by the principal or other investigators to be not eligible for enrollment in the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Kobayashi |
Organization
National Defense Medical College
Division name
Division of Respiratory Medicine, Department of Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, 359-8513, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Defense Medical College
Division name
Division of Respiratory Medicine, Department of Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
NDMC COPD Research Group
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
| 2008 | Year | 08 | Month | 11 | 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
| 2006 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 11 | Day |
Last modified on
| 2009 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001588
