UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023737 |
|---|---|
| Receipt number | R000027345 |
| Scientific Title | Novel tests to detect the cause and the lesion in patients with dizziness |
| Date of disclosure of the study information | 2016/10/03 |
| Last modified on | 2025/02/28 16:39:49 |
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Basic information
Public title
Novel tests to detect the cause and the lesion in patients with dizziness
Acronym
Novel tests for dizziness
Scientific Title
Novel tests to detect the cause and the lesion in patients with dizziness
Scientific Title:Acronym
Novel tests for dizziness
Region
| Japan |
Condition
Condition
idiopathic dizziness or vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect the cause and the lesion in patients with idiopathic dizziness or vertigo
Basic objectives2
Others
Basic objectives -Others
1.the detection of lesion in video Head Impulse Test, 2.the detection of CTP from middle ear, 3.the detection of antibody against inner ear
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage: detected/(detected + not detected)x100 in video Head Impulse Test, the detection of CTP from middle ear and the detection of antibody against inner ear
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 | Maneuver |
Interventions/Control_1
1.video Head Impulse Test
2.washing by saline in middle ear through a penetration of tympanic membrane (0,3mL)
3.collecting of serum by blood sampling (0.5mL)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.the patients who want to detect the caus and the lesion for dizziness or vertigo
2.age >= 16, any gender
3.the patients referred to Kyushu University Hospital or Chidoribashi General Hospital
4.imformed consented
Key exclusion criteria
5.to have allergy to local anesthesic agents
6.to have severe cervical spondylosis or dissection of vertebral artery
7.the patients without consent
8.others (the patients to be determined as inadequate candidate)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Otorhinolaryngology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN
TEL
092-642-5668
nakataka@qent.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Kubo |
Organization
Kyushu University Hospital
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN
TEL
092-642-5668
Homepage URL
kubokazu@qent.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
-
-
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
| 2016 | Year | 10 | Month | 03 | 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
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On going registration.
Management information
Registered date
| 2016 | Year | 08 | Month | 23 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027345
