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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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