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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029587


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name