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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000023737 |
Receipt No. | 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 | 2016/08/31 |
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 |
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Condition | ||
Condition | idiopathic dizziness or vertigo | |
Classification by specialty |
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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 |
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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) |
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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 |
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Age-upper limit |
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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 |
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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) |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate School of Medical Sciences, Kyushu University | ||||||
Division name | Department of Otorhinolaryngology | ||||||
Zip code | |||||||
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 |
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Organization | Kyushu University Hospital | ||||||
Division name | Department of Otorhinolaryngology, Head and Neck Surgery | ||||||
Zip code | |||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN | ||||||
TEL | 092-642-5668 | ||||||
Homepage URL | |||||||
kubokazu@qent.med.kyushu-u.ac.jp |
Sponsor | |
Institute | Kyushu University |
Institute | |
Department |
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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027345 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |