UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021703
Receipt number R000025041
Scientific Title Dynamics of facial canal for early diagnosis of peripheral facial palsy using cone-beam computed tomography
Date of disclosure of the study information 2016/04/01
Last modified on 2023/04/06 11:55:46

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Basic information

Public title

Dynamics of facial canal for early diagnosis of peripheral facial palsy using cone-beam computed tomography

Acronym

CBCT and facial palsy

Scientific Title

Dynamics of facial canal for early diagnosis of peripheral facial palsy using cone-beam computed tomography

Scientific Title:Acronym

CBCT and facial palsy

Region

Japan


Condition

Condition

peripheral facial palsy

Classification by specialty

Neurology Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

early diagnosis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

diameter of facial canal within 1 week after onset

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

Other

Interventions/Control_1

Cone-beam CT image at the early stage after onset

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with peripheral facial palsy

Key exclusion criteria

children cases

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Komori

Organization

Kochi University, School of Medicine

Division name

Department of Otolaryngology

Zip code

783-8505

Address

Kohasu, Oko-cho, Nankoku

TEL

088-880-2393

Email

komori@kochi-u.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Komori

Organization

Kochi University, School of Medicine

Division name

Department of Otolaryngology

Zip code

783-8505

Address

Kohasu, Oko-cho, Nankoku

TEL

088-880-2393

Homepage URL


Email

komori@kochi-u.ac.jp


Sponsor or person

Institute

Department of Otolaryngology, Kochi University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Otolaryngology,Ehime University,School of Medicine
Department of Otolaryngology,Takanoko Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kochi Medical School

Address

Kohasu, Oko-cho, Nankoku-shi

Tel

+81888802180

Email

komori@kochi-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

2016 Year 04 Month 01 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

0

Results

No data have been obtained from our department and related institutions.

Results date posted

2023 Year 04 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

N/A

Participant flow

N/A

Adverse events

N/A

Outcome measures

N/A

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015 Year 09 Month 16 Day

Date of IRB

2015 Year 09 Month 16 Day

Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective case series study;
All patients presenting with a peripheral facial palsy will be included in the study to investigate the relationship among CBCT images at the early stage, ENoG value, and cure rate.


Management information

Registered date

2016 Year 03 Month 31 Day

Last modified on

2023 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025041


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name