UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| 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 | 2020/02/14 (Ver. 6) |
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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 |
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| Condition | ||
| Condition | sinusitis | |
| Classification by specialty |
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| 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 | |
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| Interventions/Control_3 | |
| Interventions/Control_4 | |
| Interventions/Control_5 | |
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| Interventions/Control_7 | |
| Interventions/Control_8 | |
| Interventions/Control_9 | |
| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Healthy subjects (n=10)
Sinusitis patients (n=20) |
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| 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 |
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| Target sample size | 30 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 | 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | notmal subjects and sinitis patients |
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| Participant flow | At the time of thermography (a few minites) |
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| Adverse events | nothing |
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| Outcome measures | applicability of thermography for diagnothing sinitis |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Main results already published | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| 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 |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038661 |
