UMIN-CTR Clinical Trial

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
Email	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
Email	jibika@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Otolaryngology, Head&Neck Department
Institute
Department

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
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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029587