UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030664 |
|---|---|
| Receipt number | R000035010 |
| Scientific Title | Quantitative evaluation of swallowing dysfunction using 320-row area detector CT and high-resolution manometry |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/12/08 21:33:17 |
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Basic information
Public title
Quantitative evaluation of swallowing dysfunction using 320-row area detector CT and high-resolution manometry
Acronym
Swallowing evaluation by ADCT and manometry
Scientific Title
Quantitative evaluation of swallowing dysfunction using 320-row area detector CT and high-resolution manometry
Scientific Title:Acronym
Swallowing evaluation by ADCT and manometry
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify multilaterally dysphagia situations in various diseases by evaluation of complicated conformational changes in swallowing dynamics using 320-row area detector CT (320-ADCT) and by measurement of intraluminal pressure changes in the food passage using high-resolution manometry.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Value of intraluminal pressure in swallowing from nasopharynx to cervical esophagus
Key secondary outcomes
Value of conformational changes in swallowing from nasopharynx to cervical esophagus
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
high-resolution manometry(Device, equipment)
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 or suspicion of dysphagia
Patients who can make an explicit statement
Patients without severe systemic complications
Patients with written informed consents before an initiation of studies
Key exclusion criteria
Patient with serious psychiatric disorder
Patient who is considered to be ineligible for this study by the doctor in charge
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Rumi |
| Middle name | |
| Last name | Ueha |
Organization
the University of Tokyo
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
UEHAR-OTO@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Rumi |
| Middle name | |
| Last name | Ueha |
Organization
the University of Tokyo
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
http://www.h.u-tokyo.ac.jp/orl/wp-content/uploads/kenkyu_ichiran201705.pdf
UEHAR-OTO@h.u-tokyo.ac.jp
Sponsor or person
Institute
the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the University of Tokyo
Address
7-3-1 Hongo Bunyko-ku, Tokyo
Tel
0338155411
UEHAR-OTO@h.u-tokyo.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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2025 | 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
| 2018 | Year | 01 | Month | 03 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035010
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
