UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040116 |
|---|---|
| Receipt number | 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 | 2021/10/22 12:46:37 |
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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
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
harukatohara@hotmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 11 | Day |
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
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045741
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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