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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name