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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029904
Receipt No. R000034162
Scientific Title Investigation of the method of new surface anesthesia with using ultrasound energy.
Date of disclosure of the study information 2017/12/01
Last modified on 2019/05/13

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Basic information
Public title Investigation of the method of new surface anesthesia with using ultrasound energy.
Acronym Investigation of the method of new surface anesthesia.
Scientific Title Investigation of the method of new surface anesthesia with using ultrasound energy.
Scientific Title:Acronym Investigation of the method of new surface anesthesia.
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the safety of the method of new surface anesthesia with using ultrasound energy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The safety of the method of new surface anesthesia with using ultrasound energy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control
Interventions/Control_2 Ultrasound
Interventions/Control_3 Lidocaine
Interventions/Control_4 Ultrasound + Lidocaine
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 More than 20 years old
Male and female
Healthy
The person who can agree with this test by the person.
Key exclusion criteria Lidocaine allergy
Pregnancy
The person who is not suitable for this test by the evaluation of the doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Harada
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code 755-8505
Address 1-1-1 Minamikogushi, Ube, Yanaguchi
TEL 0836222299
Email harako@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Harada
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code 755-8505
Address 1-1-1 Minamikogushi, Ube, Yanaguchi
TEL 0836222299
Homepage URL
Email harako@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Yamaguchi University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization clinical research center, Yamaguchi university hospital
Address 1-1-1 Minamikogush, Ube, Yamaguchii
Tel 0836-22-2428
Email clin_res@yamaguchi-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
2017 Year 12 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 Preinitiation
Date of protocol fixation
2007 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 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
2017 Year 11 Month 09 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034162

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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