UMIN-CTR Clinical Trial

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 Middle name Last name Takashi Nakagawa
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
Email	nakataka@qent.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuhiko Kubo
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
Email	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
Email

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
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
Anticipated trial start date	2016 Year 10 Month 03 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	2016 Year 08 Month 23 Day
Last modified on	2016 Year 08 Month 31 Day

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

Contact us.