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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014728
Receipt No. R000017115
Scientific Title Vagus Nerve Stimulation Post marketing surveillance in Japan
Date of disclosure of the study information 2014/07/31
Last modified on 2014/07/31

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Basic information
Public title Vagus Nerve Stimulation
Post marketing surveillance in Japan
Acronym Vagus Nerve Stimulation
Post marketing surveillance in Japan
Scientific Title Vagus Nerve Stimulation
Post marketing surveillance in Japan
Scientific Title:Acronym Vagus Nerve Stimulation
Post marketing surveillance in Japan
Region
Japan

Condition
Condition Refractory epilepsy
Classification by specialty
Medicine in general Neurology Pediatrics
Psychiatry Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Respond to the attached condition of marketing approval, on the basis of the provisions of Article 14-4 (re-examination of new medical device) of the Pharmaceutical Affairs Law of Japan, to value the efficacy and safety of Vagus Nerve Stimulation on Post marketing surveillance in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lead Impedance, Infection,
Adverse Event, Seizure Frequency
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Not applicable
Key exclusion criteria Not applicable
Target sample size 300

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takashi Inai
Organization NIHON KOHDEN CORPORATION
Division name Quality Management Division
Zip code
Address 3-14-20 Higashinakano, Nakano-ku,Tokyo
TEL 03-5996-8022
Email Takashi_Inai@mb1.nkc.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shiro Okada
Organization NIHON KOHDEN CORPORATION
Division name Import Business Operations
Zip code
Address 3-14-20 Higashinakano, Nakano-ku,Tokyo
TEL 03-5348-1574
Homepage URL
Email Shiro_Okada@mb3.nkc.co.jp

Sponsor
Institute NIHON KOHDEN CORPORATION
Institute
Department

Funding Source
Organization None
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
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
2014 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2010 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2014 Year 07 Month 31 Day
Last modified on
2014 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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