UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029904 |
|---|---|
| Receipt number | 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 09:02:26 |
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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
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
harako@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034162
