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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033896
Receipt No. R000038661
Scientific Title Application of thermography for diagnosing sinusitis
Date of disclosure of the study information 2018/08/25
Last modified on 2018/08/25

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Basic information
Public title Application of thermography for diagnosing sinusitis
Acronym Thermography of sinusitis
Scientific Title Application of thermography for diagnosing sinusitis
Scientific Title:Acronym Thermography of sinusitis
Region
Japan

Condition
Condition sinusitis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination as to whether thermography is useful for sinusitis diagnosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Thermographical difference between with and without sinusitis
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy subjects (n=10)
Sinusitis patients (n=20)
Key exclusion criteria Severe allergic rhinitis patients
Patient with malignant tumors of rhinosinusitis
Patient with nasal bleeding
Patients who are judged inappropriate as the su bject by the research director
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Ishimaru
Organization JIJUNKAI HYOTAN-MACHI ENT CLINIC
Division name Department of Otorhinolaryngology
Zip code
Address Hyotan-machi 2-13, Kanazawa, Ishikawa, Japan
TEL 076-231-1958
Email taishimaru-alg@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Ishimaru
Organization JIJUNKAI HYOTAN-MACHI ENT CLINIC
Division name Department of Otorhinolaryngology
Zip code
Address Hyotan-machi 2-13, Kanazawa, Ishikawa, Japan
TEL 076-231-1958
Homepage URL
Email taishimaru-alg@umin.ac.jp

Sponsor
Institute JIJUNKAI HYOTAN-MACHI ENT CLINIC
Institute
Department

Funding Source
Organization JIJUNKAI HYOTAN-MACHI ENT CLINIC
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
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 耳順会 ひょうたん町耳鼻咽喉科医院(石川県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Noninvasive observational study

Management information
Registered date
2018 Year 08 Month 25 Day
Last modified on
2018 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038661

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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