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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038579
Receipt No. R000043962
Scientific Title Reliability and validity study of placebo thumbtack needle
Date of disclosure of the study information 2019/11/15
Last modified on 2019/11/14

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Basic information
Public title Reliability and validity study of placebo thumbtack needle
Acronym Reliability and validity study of placebo thumbtack needle
Scientific Title Reliability and validity study of placebo thumbtack needle
Scientific Title:Acronym Reliability and validity study of placebo thumbtack needle
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of reliability and validity of placebo thumbtack needle
Basic objectives2 Others
Basic objectives -Others Reliability and validity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Discrimination of intervention type
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 thumbtack needle
Interventions/Control_2 Placebo thumbtack needle
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.Subjects who can communicate in japanese
2.Subjects who are not suffering from an imunne disorder
3.Subjets who have a tendency to bleed
Key exclusion criteria Subjects who do not meen inclusion criteria
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Kimura
Organization Tokyo Ariake University of Medical and Health sciences
Division name Graduate school of Health Sciences
Zip code 135-0063
Address 2-9-1 Ariake,Koto-ku,Tokyo
TEL 03-6703-7018
Email kimura@tau.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Tachikawa
Organization Tokyo Ariake University of Medical and Health sciences
Division name Graduate school of Health Sciences
Zip code 135-0063
Address 2-9-1 Ariake,Koto-ku,Tokyo
TEL 03-6703-7000
Homepage URL
Email 5218001@tau.ac.jp

Sponsor
Institute Tokyo Ariake University of Medical and Health sciences
Institute
Department

Funding Source
Organization Tokyo Ariake University of Medical and Health sciences
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 Tokyo Ariake University of Medical and Health Sciences
Address 2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel +08-3-6703-7000
Email kida@tau.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
2019 Year 11 Month 15 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
2019 Year 08 Month 23 Day
Date of IRB
2019 Year 08 Month 23 Day
Anticipated trial start date
2019 Year 11 Month 15 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
2019 Year 11 Month 14 Day
Last modified on
2019 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043962

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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