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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022807
Receipt No. R000026284
Scientific Title The study for evaluation of the neurosurgical instrumentation made by the shape memory alloys
Date of disclosure of the study information 2017/03/31
Last modified on 2016/06/20

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Basic information
Public title The study for evaluation of the neurosurgical instrumentation made by the shape memory alloys
Acronym The study for evaluation of the neurosurgical instrumentation made by the shape memory alloys
Scientific Title The study for evaluation of the neurosurgical instrumentation made by the shape memory alloys
Scientific Title:Acronym The study for evaluation of the neurosurgical instrumentation made by the shape memory alloys
Region
Japan

Condition
Condition brain and spinal disease
Classification by specialty
Neurosurgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In neurosurgery operation, we evaluate the difference using shape memory alloys or not in operation time, operation maneuvability and surgery-related complications.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes surgical meneuvablity, surgery-related complication
Key secondary outcomes surigical times, estimated blood loss during surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 the patient using newly-desugned instrument
Interventions/Control_2 or not
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

Not applicable
Gender Male and Female
Key inclusion criteria 1, the patient underewnt brain and spine surgery
2, patients' age equal and over 20
3, patient can understand the importance of this study
Key exclusion criteria The reserchers think that the patients are appropriate for this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Ito
Organization Shinshu university
Division name neurosurgery
Zip code
Address Asahi 3-1-1 matumoto city
TEL 0263-37-2690
Email kitoh@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Ito
Organization Shinshu university
Division name Neurosurgery
Zip code
Address Asahi Matsumoto
TEL 0263-37-2690
Homepage URL http://www.shinshu-u.ac.jp/faculty/medicine/chair/i-noge/
Email kitoh@shinshu-u.ac.jp

Sponsor
Institute Shinshu university, school of medicine, department of neurosurgery
Institute
Department

Funding Source
Organization Shinshu university, school of medicine, department of neurosurgery
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 06 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 07 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 06 Month 20 Day
Last modified on
2016 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026284

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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