UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003778 |
|---|---|
| Receipt number | R000004574 |
| Scientific Title | Safety, bone tissue adhesion and bone regeneration assessment of the concentrated growth factor of autologous fibrin gel in bone grafts Compared to that of beriplast P combi-set; |
| Date of disclosure of the study information | 2010/08/01 |
| Last modified on | 2010/06/18 14:56:49 |
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Basic information
Public title
Safety, bone tissue adhesion and bone regeneration assessment of the concentrated growth factor of autologous fibrin gel in bone grafts Compared to that of beriplast P combi-set;
Acronym
Safety, bone tissue adhesion and bone regeneration assessment of the concentrated growth factor of autologous fibrin gel in bone grafts Compared to that of beriplast P combi-set;
Scientific Title
Safety, bone tissue adhesion and bone regeneration assessment of the concentrated growth factor of autologous fibrin gel in bone grafts Compared to that of beriplast P combi-set;
Scientific Title:Acronym
Safety, bone tissue adhesion and bone regeneration assessment of the concentrated growth factor of autologous fibrin gel in bone grafts Compared to that of beriplast P combi-set;
Region
| Japan |
Condition
Condition
cleft lip, alveolus and palate
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety and bone tissue adhesion and bone regeneration assessment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
infection
Bone formation
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
secondary bone graft
Key exclusion criteria
malignant tumor
osteomyelitis
easy bleeding
anemia
infection
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mika Shinoyama |
Organization
Kawasaki Medical School
Division name
Plastic and Reconstructive Surgery
Zip code
Address
577Mastushima Kurashiki city, Okayama
TEL
0864621111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Shinoyama |
Organization
Kawasaki Medical School
Division name
Plastic and Reconstructive Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery,Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical 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
川崎医科大学附属病院(岡山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The research doesn't start.
Management information
Registered date
| 2010 | Year | 06 | Month | 18 | Day |
Last modified on
| 2010 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004574
