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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025379
Receipt No. R000029204
Scientific Title Inhibition of osteogenesis for the treatment of craniosynostosis by using new biomaterials.
Date of disclosure of the study information 2017/03/31
Last modified on 2016/12/22

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Basic information
Public title Inhibition of osteogenesis for the treatment of craniosynostosis by using new biomaterials.
Acronym The new concept of the treatment of craniosynostosis.
Scientific Title Inhibition of osteogenesis for the treatment of craniosynostosis by using new biomaterials.
Scientific Title:Acronym The new concept of the treatment of craniosynostosis.
Region
Japan

Condition
Condition Craniosynostosis
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficiency of polyrotaxane as an inhibitor of the osteogenesis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes micro CT, histological evaluation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Fragment of the cranial bone will be used for this study.
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
0 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who will undertake suturectomy for the treatment of craniosynostosis.
Key exclusion criteria none
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nuri
Organization Osaka Medical College
Division name Department of Plastic and Reconstructive Surgery,
Zip code
Address 2-7, Daigaku-cho, Takatsuki City, Osaka
TEL 072-683-1221
Email pla042@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nuri
Organization Osaka Medical College
Division name Department of Plastic and Reconstructive Surgery,
Zip code
Address 2-7, Daigaku-cho, Takatsuki City, Osaka
TEL 072-683-1221
Homepage URL
Email pla042@osaka-med.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
Email

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
2017 Year 03 Month 31 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
Date of protocol fixation
2016 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 31 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
2016 Year 12 Month 22 Day
Last modified on
2016 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029204

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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