UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019949 |
|---|---|
| Receipt number | R000022601 |
| Scientific Title | Prospective study of Cochlin-Tomoprotein (CTP) detection test for making a definite diagnosis of perilymphatic fistula |
| Date of disclosure of the study information | 2015/11/27 |
| Last modified on | 2022/06/02 12:52:13 |
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Basic information
Public title
Prospective study of Cochlin-Tomoprotein (CTP) detection test for making a definite diagnosis of perilymphatic fistula
Acronym
CTP detection for definite diagnosis of perilymphatic fistula
Scientific Title
Prospective study of Cochlin-Tomoprotein (CTP) detection test for making a definite diagnosis of perilymphatic fistula
Scientific Title:Acronym
CTP detection for definite diagnosis of perilymphatic fistula
Region
| Japan |
Condition
Condition
perilymphatic fistula
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the perilymphatic fistula by using Cochlin-Tomoprotein (CTP) test among the patients with hearing loss or vertigo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of CTP positive patients among the patients with clinical perilymphatic fistula
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The extraction of cleaning liquid of middle ear
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
patients with clinical diagnosed perilymphatic fistula
Key exclusion criteria
Patients without prior consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2323
tadaoy@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2323
Homepage URL
tadaoy@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Otorhinolaryngology
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university
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
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-741-2111
tadaoy@med.nagoya-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
| 2015 | Year | 11 | Month | 27 | 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
| 2013 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2022 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022601
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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