UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014728 |
|---|---|
| Receipt number | R000017115 |
| Scientific Title | Vagus Nerve Stimulation Post marketing surveillance in Japan |
| Date of disclosure of the study information | 2014/07/31 |
| Last modified on | 2019/09/13 12:10:23 |
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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
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
Takashi_Inai@mb1.nkc.co.jp
Public contact
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
Shiro_Okada@mb3.nkc.co.jp
Sponsor or person
Institute
NIHON KOHDEN CORPORATION
Institute
Department
Personal name
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
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
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
385
Results
DMAH(Designated Marketing Authorization Holder) for the device transferred from NIHON KOHDEN CORPORATION to other company.
This study terminated as NIHON KOHDEN CORPORATION.
Results date posted
| 2019 | Year | 09 | Month | 13 | Day |
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
Terminated
Date of protocol fixation
| 2010 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
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
| 2019 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017115
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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