UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019511
Receipt number R000022565
Scientific Title Usage of nasopharyngeal tube electrodes
Date of disclosure of the study information 2015/11/09
Last modified on 2015/11/09 13:49:51

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Basic information

Public title

Usage of nasopharyngeal tube electrodes

Acronym

Usage of nasopharyngeal tube electrodes

Scientific Title

Usage of nasopharyngeal tube electrodes

Scientific Title:Acronym

Usage of nasopharyngeal tube electrodes

Region

Japan


Condition

Condition

all spinal surgery

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To protect spinal cord paresis, we use electrode to confirm safety surgery.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

derivation of paresis

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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Usage of nasopharyngeal tube electrodes

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

15 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

all spinal surgery

Key exclusion criteria

patient who has nasal injury

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shiro Imagama

Organization

Nagoya University

Division name

Orthopedics

Zip code


Address

65 Tsurumai Syowaku Nagoya Aichi

TEL

052-741-2111

Email

imagama@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Zenya Ito

Organization

Nagoya University

Division name

Orthopedics

Zip code


Address

65 Tsurumai Syowaku Nagoya Aichi

TEL

052-741-2111

Homepage URL


Email

z.ito@nifty.com


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Nagoya University

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

2015 Year 11 Month 09 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

Preinitiation

Date of protocol fixation

2014 Year 10 Month 17 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 17 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

2015 Year 10 Month 27 Day

Last modified on

2015 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name