UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005949 |
|---|---|
| Receipt number | 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 19:37:51 |
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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
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
Sponsor or person
Institute
DENKA SEIKEN Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007030
