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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005949
Receipt No. R000007030
Scientific Title The correlation studies on the in vitro diagnosis rapid test kit, QuickNavi-Adeno with other in vitro diagnosis rapid test kits by using keratoconjunctive swab.
Date of disclosure of the study information 2011/07/07
Last modified on 2011/07/07

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Basic information
Public title The correlation studies on the in vitro diagnosis rapid test kit, QuickNavi-Adeno with other in vitro diagnosis rapid test kits by using keratoconjunctive swab.
Acronym The correlation studies on the in vitro diagnosis rapid test kit, QuickNavi-Adeno with other in vitro diagnosis rapid test kits by using keratoconjunctive swab.
Scientific Title The correlation studies on the in vitro diagnosis rapid test kit, QuickNavi-Adeno with other in vitro diagnosis rapid test kits by using keratoconjunctive swab.
Scientific Title:Acronym The correlation studies on the in vitro diagnosis rapid test kit, QuickNavi-Adeno with other in vitro diagnosis rapid test kits by using keratoconjunctive swab.
Region
Japan

Condition
Condition Epidemic Keratoconjunctivitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For a clinical evaluation of QuickNavi-adeno, two correlation studies were performed with clinical keratoconjunctive swab specimen in 2009 season, one was correlation studies on the QuickNavi-adeno with other in vitro diagnosis rapid tests, and another was correlation study on the QuickNavi-adeno with polymerase chain reaction (PCR) method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Detection the antigen of adenovirus
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Quick-navi adeno
Interventions/Control_2 Check Ad or capilia adeno
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 The patients who seemed to be adeno virus infection, and also who gave us the agreement with the aim of this clinical evaluation.
Key exclusion criteria None
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miki Uchino
Organization Ryogoku Eye Clinic
Division name Ophthalmology director
Zip code
Address 4-33-12 Ryogoku Sumida-ku Tokyo, JAPAN
TEL 03-5600-6886
Email

Public contact
Name of contact person
1st name
Middle name
Last name Miki Uchino
Organization Ryogoku Eye Clinic
Division name Ophthalmology director
Zip code
Address
TEL 03-5600-6886
Homepage URL
Email

Sponsor
Institute DENKA SEIKEN Co.,Ltd.
Institute
Department

Funding Source
Organization DENKA SEIKEN Co.,Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Iidabashi Eye Clinic
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 医療法人社団慶翔会 両国眼科クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 07 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 Completed
Date of protocol fixation
2009 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2009 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 07 Day
Last modified on
2011 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007030

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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