UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of a new fiber-grating vision sensor for assessing swallowing functions
Title of the study (Brief title)	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	TETSUYA TSUJI
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3833
Email	daihyou@ml.keio.jp

Public contact
Name of contact person	TETSUYA TSUJI
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3833
Homepage URL
Email	daihyou@ml.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018711