UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022807 |
|---|---|
| Receipt number | 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 17:07:25 |
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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
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/
kitoh@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university, school of medicine, department of neurosurgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026284
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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