UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049177 |
|---|---|
| Receipt number | R000056015 |
| Scientific Title | Distribution of TRPM8 channels and thermo-fluid analysis of nasal sinus sensory perception to elucidate the cause of nasal obstruction Analysis of nasal sinus airflow using |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/11/17 16:01:22 |
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Basic information
Public title
Distribution of TRPM8 channels and thermo-fluid analysis of nasal sinus sensory perception to elucidate the cause of nasal obstruction
Analysis of nasal sinus airflow using
Acronym
Analysis of nasal sinus TRPM8 channel distribution and nasal sinus airflow
Scientific Title
Distribution of TRPM8 channels and thermo-fluid analysis of nasal sinus sensory perception to elucidate the cause of nasal obstruction
Analysis of nasal sinus airflow using
Scientific Title:Acronym
Analysis of nasal sinus TRPM8 channel distribution and nasal sinus airflow
Region
| Japan |
Condition
Condition
rhinosinusitis, nasal septal deviation, allergic rhinitis, paranasal sinus tumor
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidate the distribution of nasal airflow and temperature-sensing TRPM8 in the nasal sinuses
Basic objectives2
Others
Basic objectives -Others
Nasal sinus morphology with airflow to areas of high TRPM8 distribution
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal sinus tissue immunostaining to confirm the site of presence and identify protein levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Collection of nasal sinus tissue to be discarded at surgery
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery for nasal sinus disease
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Hosokawa |
Organization
Saitama medical university hospital
Division name
Otorhinolaryngology
Zip code
3500495
Address
38, Muro Hongo, Muroyama-cho, Iruma-gun, Saitama, Japan
TEL
0492711253
hosokawa.yu@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Hosokawa |
Organization
Saitama medical university hospital
Division name
Otorhinolaryngology
Zip code
3500495
Address
38, Muro Hongo, Muroyama-cho, Iruma-gun, Saitama, Japan
TEL
0492711253
Homepage URL
hosokawa.yu@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital IRB
Address
38, Muro Hongo, Muroyama-cho, Iruma-gun, Saitama, Japan
Tel
0492761111
hirb@saitama-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056015
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
