UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Maximal volume change
Oral transit time.
Pharyngeal transit time.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

daihyou@ml.keio.jp

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

Email

daihyou@ml.keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Keio University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）

Date of disclosure of the study information

2015

Year

01

Month

05

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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