UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study for evaluation of the neurosurgical instrumentation made by the shape memory alloys
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kiyoshi Ito
Organization	Shinshu university
Division name	neurosurgery
Address	Asahi 3-1-1 matumoto city
TEL	0263-37-2690
Email	kitoh@shinshu-u.ac.jp

Public contact
Name of contact person	Kiyoshi Ito
Organization	Shinshu university
Division name	Neurosurgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 06 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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