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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021625
Receipt No. R000024939
Scientific Title Detection of stapedial reflex using a Quarter-pixel Detector CT
Date of disclosure of the study information 2018/05/12
Last modified on 2018/01/17

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Basic information
Public title Detection of stapedial reflex using a Quarter-pixel Detector CT
Acronym Stapedial reflex and QDCT
Scientific Title Detection of stapedial reflex using a Quarter-pixel Detector CT
Scientific Title:Acronym Stapedial reflex and QDCT
Region
Japan

Condition
Condition normal volunteer
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To visualize the stapedial reflex using a QDCT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Distance between the pyramidal eminence and the stapes head with and without acoustic reflex
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 acoustic stimuli evoking a stapedial reflex
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Normal volunteer with informed consent

Normal ear drum

Positive stapedial reflex
Key exclusion criteria Subjects without consent
Subjects scheduled for head CT scan within 1 year
Subjects without stapedial reflex
Subjects with ear drum pathology
Subjects those are not suitable for CT scan
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Harukazu Hiraumi
Organization Iwate Medical University
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Email hhiraumi@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Harukazu Hiraumi
Organization Iwate Medical University
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Homepage URL
Email hhiraumi@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Iwate Medical University
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
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
2018 Year 05 Month 12 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 Completed
Date of protocol fixation
2016 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 31 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 26 Day
Last modified on
2018 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024939

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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