UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035685 |
|---|---|
| Receipt number | 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 | 2023/02/03 19:39:47 |
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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
ahorii@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamagishi |
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
ymg_ent_niigata@yahoo.co.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 03 | Day |
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
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
