UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033896 |
|---|---|
| Receipt number | R000038661 |
| Scientific Title | Application of thermography for diagnosing sinusitis |
| Date of disclosure of the study information | 2018/08/25 |
| Last modified on | 2020/02/14 22:45:19 |
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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 | Tadashi |
| Middle name | |
| Last name | Ishimaru |
Organization
JIJUNKAI HYOTAN-MACHI ENT CLINIC
Division name
Department of Otorhinolaryngology
Zip code
9200845
Address
Hyotan-machi 2-13, Kanazawa, Ishikawa, Japan
TEL
076-231-1958
taishimaru-alg@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ishimaru |
| Middle name | |
| Last name | Tadashi |
Organization
JIJUNKAI HYOTAN-MACHI ENT CLINIC
Division name
Department of Otorhinolaryngology
Zip code
9200845
Address
Hyotan-machi 2-13, Kanazawa, Ishikawa, Japan
TEL
076-231-1958
Homepage URL
taishimaru-alg@umin.ac.jp
Sponsor or person
Institute
JIJUNKAI HYOTAN-MACHI ENT CLINIC
Institute
Department
Personal name
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
Ishikawa Medical Association
Address
Kuratsukihigashi 2-48, Kanazawa, Ishikawa, Japan
Tel
076-239-3800
kosaka@ishikawa.med.or.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
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
https://www.thieme-connect.com/products/ejournals/pdf/10.1055/s-0039-1698778.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/pdf/10.1055/s-0039-1698778.pdf
Number of participants that the trial has enrolled
30
Results
The shape of the maxillary and/or frontal sinuses was determined based on
regions indicating increased temperature in patients with sinusitis. The region with
increasing temperature was statistically visualized, and the significant side (t test,p<0.05) coincided with the maxillary shadow on X-ray imaging.
Results date posted
| 2020 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
notmal subjects and sinitis patients
Participant flow
At the time of thermography (a few minites)
Adverse events
nothing
Outcome measures
applicability of thermography for diagnothing sinitis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 11 | Day |
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
| 2020 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038661
