UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016108 |
|---|---|
| Receipt number | R000018711 |
| Scientific Title | Evaluation of a new fiber-grating vision sensor for assessing swallowing functions |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2018/07/09 13:53:23 |
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Basic information
Public title
Evaluation of a new fiber-grating vision sensor for assessing swallowing functions
Acronym
Evaluation of a new fiber-grating vision sensor for assessing swallowing functions
Scientific Title
Evaluation of a new fiber-grating vision sensor for assessing swallowing functions
Scientific Title:Acronym
Evaluation of a new fiber-grating vision sensor for assessing swallowing functions
Region
| Japan |
Condition
Condition
Healthy subjects and patients with esophageal cancer before and after operation.
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm reliability and varidity of a newly developed three-dimention fiber-grating vision sensor for assessing swallowing functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximal volume change
Oral transit time.
Pharyngeal transit time.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluation of swallowing function using videofluorography (VF)
VF is performed using Iopamidol which was diluted 2 -fold with water or mixed with jelly. The subjects are instructed to hold the contrast medium placed in the mouth until the command to swallow is given, then to swallow naturally in a vertical sitting position. Small amount of the contrast medium are placed in the subject`s mouth using a syringe, and jelly containing the contrast medium is placed in the mouth with a teaspoon. Just before the command to swallow, the fluoroscope is activated. The command to swallow is immediately given and the subject swallows the contrast medium.
Evaluation of swallowing function using 3-D fiber-grating vision sensor and surface electromyography (EMG)
Two surface EMG electrodes are placed on the Suprahyoid Muscles. 3-D fiber-grating vision sensor is attached to the seat. The subjects are instructed to hold the contrast medium placed in the mouth until the command to swallow is given, then to swallow naturally in a vertical sitting position. Small amount of the contrast medium are placed in the subject`s mouth using a syringe, and jelly containing the contrast medium is placed in the mouth with a teaspoon. The command to swallow is immediately given and the subject swallows the contrast medium.
Evaluation of reliability and varidity.
We Confirm the reliability and varidity of the 3-D fiber-grating vision sensor using Intraclass Correlation (ICC) between two measurements at an interval of one day or more.
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
1. Inpatients with thoracic esophageal cancer before and after operation in keio University hospital.
2. Healthy subjects.
Key exclusion criteria
1. Subjects who have difficulty with communication.
2. Subjects who had previous operation of head and neck or brain disease.
3. Subjects with iodinated allergy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TETSUYA TSUJI |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
daihyou@ml.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TETSUYA TSUJI |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
Homepage URL
daihyou@ml.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2018 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018711
