UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019499 |
|---|---|
| Receipt number | R000022546 |
| Scientific Title | Comparison between quantitative evaluation with a new digitalized suction system and qualitative evaluation with a conventional suction system for the amount of air leakage after lung resection |
| Date of disclosure of the study information | 2015/10/26 |
| Last modified on | 2015/10/26 12:33:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison between quantitative evaluation with a new digitalized suction system and qualitative evaluation with a conventional suction system for the amount of air leakage after lung resection
Acronym
Comparison between quantitative evaluation with a new digitalized suction system and qualitative evaluation with a conventional suction system for the amount of air leakage after lung resection
Scientific Title
Comparison between quantitative evaluation with a new digitalized suction system and qualitative evaluation with a conventional suction system for the amount of air leakage after lung resection
Scientific Title:Acronym
Comparison between quantitative evaluation with a new digitalized suction system and qualitative evaluation with a conventional suction system for the amount of air leakage after lung resection
Region
| Japan |
Condition
Condition
lung resection
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study was to investigate the management criterion by comparing Thopaz and a conventional suction system.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
In the evaluation of the amount of air leakage using the conventional system, the degree was classified into four categories
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 32 | years-old | <= |
Age-upper limit
| 76 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
none
Key exclusion criteria
Patients with pneumonectomy or bleeding tendency
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Yokoi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Thoracic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2375
hishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Futoshi Ishiguro |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Thoracic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2375
Homepage URL
hishi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
covidien japan
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | 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
none
Management information
Registered date
| 2015 | Year | 10 | Month | 26 | Day |
Last modified on
| 2015 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022546
