UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024125 |
|---|---|
| Receipt number | R000027779 |
| Scientific Title | Asssessment of bioabsorbable hydroxyapatite for craniofacial surgery |
| Date of disclosure of the study information | 2016/09/21 |
| Last modified on | 2016/09/21 21:47:53 |
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Basic information
Public title
Asssessment of bioabsorbable hydroxyapatite for craniofacial surgery
Acronym
Asssessment of bioabsorbable hydroxyapatite
Scientific Title
Asssessment of bioabsorbable hydroxyapatite for craniofacial surgery
Scientific Title:Acronym
Asssessment of bioabsorbable hydroxyapatite
Region
| Japan |
Condition
Condition
Bone defect at craniofacial region
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of bioabsorbable hydroxyapatite and collagen complex
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The bone volume 1 year after the operation
Key secondary outcomes
The number of patient-controlled intravenous analgesia use
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Alveolar cleft, the patient performed cranioplasty for the defect of the cranium
Key exclusion criteria
THe patients of osteogenesis dysostosis, or chromosome aberration.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kishi |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633814
kkishi@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Sakamoto |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633814
Homepage URL
ysakamoto@z8.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2016 | Year | 09 | Month | 21 | Day |
Last modified on
| 2016 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027779
