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

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 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

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

Value
https://center6.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