UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044296
Receipt number R000050600
Scientific Title Video ultrasonographic examination of swallowing
Date of disclosure of the study information 2021/05/23
Last modified on 2021/05/23 00:23:55

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Basic information

Public title

Video ultrasonographic examination of swallowing

Acronym

Video ultrasonographic examination of swallowing

Scientific Title

Video ultrasonographic examination of swallowing

Scientific Title:Acronym

Video ultrasonographic examination of swallowing

Region

Japan


Condition

Condition

Dysphagia

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish ultrasonographic examination of swallowing

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Sensitivity and specificity of dysphagia by ultrasound

Key secondary outcomes

Saliva pooling, pharyngeal residual, Swallowing reflex, Early pharyngeal inflow, vocal cord paralysis, Tongue fasciculation, Thyroid tumor


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Ultrasound and endoscopy (single and simultaneous examination)

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 dysphagia visited department of otolaryngology, Shin-Oyama city hospital

Key exclusion criteria

Patients with active epistaxis
Patients who can not intake carbonated water

Target sample size

31


Research contact person

Name of lead principal investigator

1st name Tomohiko
Middle name
Last name Yamauchi

Organization

Shin-Oyama city hospital

Division name

Otolaryngology

Zip code

323-0827

Address

2251-1 Hitotonoya, Oyama, Tochigi

TEL

+81285360200

Email

96093ty@jichi.ac.jp


Public contact

Name of contact person

1st name Tomohiko
Middle name
Last name Yamauchi

Organization

Shin-Oyama city hospital

Division name

Otolaryngology

Zip code

323-0827

Address

2251-1 Hitotonoya, Oyama, Tochigi

TEL

+81285360200

Homepage URL


Email

96093ty@jichi.ac.jp


Sponsor or person

Institute

Shin-Oyama city hospital

Institute

Department

Personal name



Funding Source

Organization

Shin-Oyama city hospital

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

Shin-Oyama city hospital

Address

2251-1 Hitotonoya, Oyama, Tochigi

Tel

+81285360200

Email

96093ty@jichi.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

新小山市民病院


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 23 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

Enrolling by invitation

Date of protocol fixation

2021 Year 05 Month 12 Day

Date of IRB

2021 Year 05 Month 12 Day

Anticipated trial start date

2021 Year 05 Month 24 Day

Last follow-up date

2026 Year 05 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 23 Day

Last modified on

2021 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050600


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name