UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025730 |
|---|---|
| Receipt number | R000029587 |
| Scientific Title | The prognosis of olfactory performance using MRI in the eosinophilic sinusitis patients |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2022/07/25 16:29:40 |
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Basic information
Public title
The prognosis of olfactory performance using MRI in the eosinophilic sinusitis patients
Acronym
The prognosis of olfactory performance using MRI in the eosinophilic sinusitis patients
Scientific Title
The prognosis of olfactory performance using MRI in the eosinophilic sinusitis patients
Scientific Title:Acronym
The prognosis of olfactory performance using MRI in the eosinophilic sinusitis patients
Region
| Japan |
Condition
Condition
eosinophilic sinusitis
olfacotry disorder
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relation of olfactory bulb volume measured by MRI and the prognosis of olfactory performance in the patient eosinophilic chronic sinusitis with olfactory disorder and to compare the olfactory performance and the olfactory bulb volume before ESS endoscopic sinus surgery with those after ESS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation of the olfactory function test and the olfactory volume in the patients of eosinophilic chronic sinusitis with olfactory disorder.The relation of the olfactory volume before and after ESS and the prognosis of olfactory performance.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The imaging of MRI without contrast enhancement before ESS and the six months later after ESS.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients of eosinophilic chronic sinusitis
Key exclusion criteria
The difficulty of MRI imaging.
The difficulty of olfactory examinations.
Pregnancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishizaki Kazunori |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Otolaryngology, Head&Neck Department
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7307
jibika@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Murai |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Otolaryngology, Head&Neck Department
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7307
Homepage URL
jibika@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Otolaryngology, Head&Neck Department
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2017 | Year | 04 | 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
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2022 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029587
