UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041482 |
|---|---|
| Receipt number | R000047359 |
| Scientific Title | Development of non-indwelling neurosurgical instruments |
| Date of disclosure of the study information | 2020/08/24 |
| Last modified on | 2020/08/20 17:12:54 |
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Basic information
Public title
Development of non-indwelling neurosurgical instruments
Acronym
Development of non-indwelling neurosurgical instruments
Scientific Title
Development of non-indwelling neurosurgical instruments
Scientific Title:Acronym
Development of non-indwelling neurosurgical instruments
Region
| Japan |
Condition
Condition
Neurosurgical diseases
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of neurosurgical instruments with new tecnology
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease of operation time and improve surgical outcome
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Apply of newly created non-indwelling neurosurgical instruments to real surgical procedures
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with informed-consent of neurosurgical diseases in which newly created non-indwelling neurosurgical instruments are effectively available
Key exclusion criteria
Patients without informed-consent of neurosurgical diseases in which newly created non-indwelling neurosurgical instruments are effectively available
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Kikuta |
Organization
University of Fukui
Division name
Department of Neurosurgery, Division of Medicine, Faculty of Medical Sciences,
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun
TEL
+81-776-61-8387
kikuta@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Kikuta |
Organization
University of Fukui
Division name
Department of Neurosurgery, Division of Medicine, Faculty of Medical Sciences,
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun
TEL
+81-776-61-8387
Homepage URL
kikuta@u-fukui.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Division of Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Division of Medicine, Faculty of Medical Sciences, University of Fukui
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
The Research Ethics Committee of University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan
Tel
+81-776-61-8529
chiken@ml.u-fukui.ac.jp
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
| 2020 | Year | 08 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047359
