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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001310
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute NDMC COPD Research Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001588

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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