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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035685
Receipt No. R000040649
Scientific Title Clinical study of trans-tympanic silicone plug insertion for the patients with patulous Eustachian tube
Date of disclosure of the study information 2019/02/01
Last modified on 2019/07/29

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Basic information
Public title Clinical study of trans-tympanic silicone plug insertion for the patients with patulous Eustachian tube
Acronym Clinical study of trans-tympanic silicone plug insertion for the patients with patulous Eustachian tube
Scientific Title Clinical study of trans-tympanic silicone plug insertion for the patients with patulous Eustachian tube
Scientific Title:Acronym Clinical study of trans-tympanic silicone plug insertion for the patients with patulous Eustachian tube
Region
Japan

Condition
Condition patulous Eustachian tube
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Conservative treatment is undertaken for patulous Eustachian tube, but there is no established treatment method. In this study, we confirmed the safety and efficacy of the trans-tympanic silicone plug insertion.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Interview(BBK and HADS score)
Acoustic otoscope
sonotubometry
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 patients with the trans-tympanic silicone plug insertion are observed to progress.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases with no improvement with conservative treatment after 6 months or more after onset
Key exclusion criteria general condition that local surgery can not be performed under local anesthesia in the sitting position
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Arata
Middle name
Last name Horii
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Otorhinolaryngology
Zip code 9518510
Address 1-757 Asahimachi-dori , Chuo-ku, Niigata 951-8510, Japan
TEL +81-25-227-2306
Email ahorii@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Shinsuke
Middle name
Last name Ohshima
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Otorhinolaryngology
Zip code 951-8510
Address 1-757 Asahimachi-dori , Chuo-ku, Niigata 951-8510, Japan
TEL +81-25-227-2306
Homepage URL
Email sohshima@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization none
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 Niigata University Graduate School of Medical and Dental Sciences
Address 1-757 Asahimachi-dori , Chuo-ku, Niigata 951-8510, Japan
Tel +81-25-227-2306
Email r-kenkyu@adm.niigata-u.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
2019 Year 02 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 Enrolling by invitation
Date of protocol fixation
2012 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 27 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040649

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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