UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046802 |
|---|---|
| Receipt number | R000053383 |
| Scientific Title | Evaluation of normal swallowing function and pathology of swallowing dysfunction using upright computed tomography |
| Date of disclosure of the study information | 2022/02/02 |
| Last modified on | 2022/03/19 14:53:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of normal swallowing function and pathology of swallowing dysfunction using upright computed tomography
Acronym
Evaluation of swallowing function using upright CT
Scientific Title
Evaluation of normal swallowing function and pathology of swallowing dysfunction using upright computed tomography
Scientific Title:Acronym
Evaluation of swallowing function using upright CT
Region
| Japan |
Condition
Condition
normal swallowing function and dysphagia
Classification by specialty
| Pneumology | Neurology | Radiology |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate normal swallowing function using upright CT.
To clarify the pathology of swallowing dysfunction using upright CT.
Basic objectives2
Others
Basic objectives -Others
To evaluate the clinical usefulness of upright CT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological or functional parameters on images
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Upright CT
Interventions/Control_2
Conventional CT
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
1. Age equal to or more than 20 years
2. Subjects (both male and female) who understand the purpose of this study
3. Healthy volunteers with a score of 2 or less on the EAT-10 for the screening of dysphasia
4. Patients with dysphagia who are in stable general condition, who are eligible for videofluoroscopic examination of swallowing (VF)
Key exclusion criteria
1. Subjects who do not provide written informed consent
2. Known or possible pregnancy
3. Subjects with a history of allergy of barium sulphate contrast agent
4. Healthy volunteers with a score of 3 or more on the EAT-10
5. Patients with dysphagia who are not eligible for VF examination
6. Patients with dysphagia who have trouble understanding instructions due to severe dementia or aphasia
7. Subjects who have difficulty in sputum expectoration
8. Subjects who are not able to undergo CT examination
9. Claustrophobia
10. Subjects with symptoms of some kinds of disease
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Jinzaki |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1977(+81-3-3353-1977)
jinzaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Yamada |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
070-4833-4192(+81-70-4833-4192)
Homepage URL
yamada.z8@keio.jp
Sponsor or person
Institute
Department of Radiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503 (+81-3-5363-3503)
med-rinri-jimu@adst.keio.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
| 2022 | Year | 02 | Month | 02 | 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
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 02 | Month | 02 | Day |
Last modified on
| 2022 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053383
