UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011000 |
|---|---|
| Receipt number | R000012868 |
| Scientific Title | Intrapleural administration of fibrin glue for intractable pneumothorax |
| Date of disclosure of the study information | 2013/06/20 |
| Last modified on | 2017/09/02 09:08:58 |
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Basic information
Public title
Intrapleural administration of fibrin glue for intractable pneumothorax
Acronym
Intrapleural administration of fibrin glue for intractable pneumothorax
Scientific Title
Intrapleural administration of fibrin glue for intractable pneumothorax
Scientific Title:Acronym
Intrapleural administration of fibrin glue for intractable pneumothorax
Region
| Japan |
Condition
Condition
Intractable pneumothorax
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of intrapleural administration of fibrin glue for intractable pneumothorax
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of pneumothorax
Key secondary outcomes
Days untile drain removal
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
| Medicine |
Interventions/Control_1
Intrapleural administration of fibrin glue
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Intractable pneumothorax,any gender,over 18 years old,hospitalized patients
Key exclusion criteria
Unable take informed consent,infants, pregnant female,considerable other effective therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Takizawa |
Organization
Tokushima university hospital
Division name
Thoracic surgery
Zip code
Address
18-1,3 Kuramoto cho,Tokushima Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima university hospital
Division name
Department of Thoracic, Endocrine Surgery, and Oncology, University of Tokushima Graduate School
Zip code
Address
18-1,3 Kuramoto cho,Tokushima Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Thoracic, Endocrine Surgery, and Oncology, University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic, Endocrine Surgery, and Oncology, University of Tokushima Graduate School
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
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
| 2013 | Year | 06 | Month | 20 | 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
30 patients
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
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 30 | 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
| 2013 | Year | 06 | Month | 19 | Day |
Last modified on
| 2017 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012868
