UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010616 |
|---|---|
| Receipt number | R000011873 |
| Scientific Title | A clinical trial of sternal closure with rigid plate fixation (SternaLock Blu) in cardiothoracic surgery |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2013/10/30 09:06:28 |
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Basic information
Public title
A clinical trial of sternal closure with rigid plate fixation (SternaLock Blu) in cardiothoracic surgery
Acronym
Sternal closure with rigid plate fixation
Scientific Title
A clinical trial of sternal closure with rigid plate fixation (SternaLock Blu) in cardiothoracic surgery
Scientific Title:Acronym
Sternal closure with rigid plate fixation
Region
| Japan |
Condition
Condition
Aortic stenosis, Aortic regurgitation, Mitral stenosis, Mitral regurgitation, Tricuspid regurgitation
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this studyis to investigate the efficacy and safety of rigid sternal fixation with plates.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Death
Infection
Revision for bleeding
Key secondary outcomes
Pain scale
The aoumont of analgesic drug usage
Pulmonary function
Total amount of drain discharge
Computed tomography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
sternal plate
Interventions/Control_2
sternal wire
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
valvular heart disease
Key exclusion criteria
congestive heart failure
concomittant coronary artery bypass surgery
octogenearian
less than 20 years old
emergent case
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Yaku |
Organization
Koyoto Prefectural University of Medecine
Division name
Cardiovascular Surgery
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL
075-251-5752
suguru19820411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Ohira |
Organization
Koyoto Prefectural University of Medecine
Division name
Cardiovascular Surgery
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL
075-251-5752
Homepage URL
s-ohira@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, Koyoto Prefectural University of Medecine
Institute
Department
Personal name
Funding Source
Organization
Medical U&A, Inc.
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
京都府立医科大学 心臓血管外科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 07 | 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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 30 | Day |
Last modified on
| 2013 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011873
