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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040116
Receipt No. R000045741
Scientific Title Detection of aspiration risk using near-infrared fluorescent clinical test system
Date of disclosure of the study information 2020/05/01
Last modified on 2020/04/10

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Basic information
Public title Detection of aspiration risk using near-infrared fluorescent clinical test system
Acronym Detection of aspiration risk using near-infrared fluorescent clinical test system
Scientific Title Detection of aspiration risk using near-infrared fluorescent clinical test system
Scientific Title:Acronym Detection of aspiration risk using near-infrared fluorescent clinical test system
Region
Japan

Condition
Condition dysphasia
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 "Near-infrared fluorescent clinical test system" can measure the fluorescence intensity from body surface during swallowing food which containing the fluorescent dye. This study aims to investigate the reliability and validity of the ability to detect aspiration risk by comparing the results of this system with those of videoendoscopic examination of swallowing( (VE) and videofluoroscopic examination of swallowing (VF).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Methods
1.Detection of pharyngeal residue by using near-infrared fluorescent clinical test system
2.Assessment of swallowing function by VE and VF
The results obtained from each test are compared and the usefulness of the near-infrared fluorescence clinical test system is verified.
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
Device,equipment
Interventions/Control_1 Test food
water containing fluorescent dye(ICG Indocyanine Green) 0.81micromol /L
Participants take 10ml test water in each swallowing.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteer who agree to participate the study
subjects with dysphagia
Key exclusion criteria subjects those cannot perform VF due to allergy of contrast medium or gastrointestinal disease
subject who do not agree to participate the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Haruka
Middle name
Last name Tohara
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Dysphagia Rehabilitation
Zip code 113-8549
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL 03-5803-5559
Email harukatohara@hotmail.com

Public contact
Name of contact person
1st name Haruka
Middle name
Last name Tohara
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Dysphagia Rehabilitation
Zip code 113-8549
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL 03-5803-5559
Homepage URL
Email harukatohara@hotmail.com

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization General Affairs Section,faculty of dentistry,Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
Tel 03-5803-5404
Email d-hyoka.adm@tmd.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
2020 Year 05 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
2020 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 09 Day
Last modified on
2020 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045741

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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