UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031348 |
|---|---|
| Receipt number | R000035762 |
| Scientific Title | Efficacy and safety of TissuePatch for air leaks after thoracic surgery: a prospective, randomized, study . |
| Date of disclosure of the study information | 2018/02/17 |
| Last modified on | 2019/01/07 17:53:08 |
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Basic information
Public title
Efficacy and safety of TissuePatch for air leaks after thoracic surgery: a prospective, randomized, study .
Acronym
Efficacy and safety of TissuePatch for air leaks after thoracic surgery
Scientific Title
Efficacy and safety of TissuePatch for air leaks after thoracic surgery: a prospective, randomized, study .
Scientific Title:Acronym
Efficacy and safety of TissuePatch for air leaks after thoracic surgery
Region
| Japan |
Condition
Condition
lung tumor or pneumothorax
Classification by specialty
| Surgery in general | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of TissuePatch for air leak after lung resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of air leak after procedure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
TissuePatch
Interventions/Control_2
Polyglycolic acid sheet and fibrin glue
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all patients older than 20 who undergo lung surgery
Key exclusion criteria
severe complications, psychiatric disorder, a woman desired pregnancy or during pregnancy or lactation, urgent surgery, others judged as inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Homma |
Organization
University of Toyama
Division name
Department of General Thoracic and Cardiovascular Surgery
Zip code
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-7330
hommat@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Homma |
Organization
University of Toyama
Division name
Department of General Thoracic and Cardiovascular Surgery
Zip code
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-7330
Homepage URL
geka1@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefecture Citizens' Personal Development Foundation (TPCPDF)
Organization
Division
Category of Funding Organization
Local Government
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
| 2018 | Year | 02 | Month | 17 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | 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
| 2018 | Year | 02 | Month | 17 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035762
