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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013741
Receipt No. R000015967
Scientific Title Measurement of normal pharyngeal pressure with High Resolution Manometry System which has 20 circumfeferential pressure sensors.
Date of disclosure of the study information 2014/04/16
Last modified on 2019/08/18

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Basic information
Public title Measurement of normal pharyngeal pressure with High Resolution Manometry System which has 20 circumfeferential pressure sensors.
Acronym Measurement of normal pharyngeal pressure with High Resolution Manometry System.
Scientific Title Measurement of normal pharyngeal pressure with High Resolution Manometry System which has 20 circumfeferential pressure sensors.
Scientific Title:Acronym Measurement of normal pharyngeal pressure with High Resolution Manometry System.
Region
Japan

Condition
Condition Dysphagia
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find the numerical value of the healthy person's swallow pressure when using Starlet manometry system, High Resolution Manometry with 20 circumferential sensors, and estimate the difference by the swallow amount, and gender difference.
When deglutition pressure is measured by Manometry, a definitive measurement is calculated by averaging several measurements. We inspect the number of the measurement required to establish reliable deglutition pressures in normal subjects.
Basic objectives2 Others
Basic objectives -Others The difference between healthy person's swallow movement corrugation and swallow motion corrugation of a swallow obstacle patient by using Starlet manometry system.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes UES relaxation time.
The item mentioned above is evaluated at catheterization.
Key secondary outcomes The maximum pressure in the velopharynx and maximum pressure in the meso-hypopharynx were measured during swallowing.
The maximum pressure in the UES at the start of the swallowing motion.
The minimum pressure after the swallowing motion.
The maximum UES pressure after the pressure waveforms in the velopharynx and meso-hypopharynx disappeared.
The durations of pressure above baseline in the velopharynx and meso-hypopharynx regions.
The time from the point at which the UES pressure started to increase until it reached the maximum pressure at the start of the swallowing motion.
The time from when the UES pressure reached the maximum pressure until completion of the gradual decrease, after the waveforms in the velopharynx and meso-hypopharynx disappeared.

Change of the measurement values above-mentioned by the amount of volus.

The number of the measurement to establish reliable deglutition pressures.

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 50 Healthy persons
10 times saliva swallowing, 10times of swallowing water 3ml, 10times of swallowing water 5ml, and 10times of swallowing water 10ml.

Swallowing of each of which is a continuous enforcement.

For one of the healthy subjects, the use of the testing equipment to only once as a general rule, and measurement to another day is not performed.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria Person with dysphagia
Person with foreign body sensation in the throat
Person who can not be subject to inspection of using manometry because of gag reflex
Person with some sort of ill-health(For example, the common cold, hangover)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Matsusato
Middle name
Last name Tsuyumu
Organization The Jikei University School of Medicine
Division name Department of Otorhinolaryngology
Zip code 105-8471
Address 3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email tsuyumu@jikei.ac.jp

Public contact
Name of contact person
1st name Matsusato
Middle name
Last name Tsuyumu
Organization The Jikei University School of Medicine
Division name Department of Otorhinolaryngology
Zip code 105-8471
Address 3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email tsuyumu@jikei.ac.jp

Sponsor
Institute Department of Otorhinolaryngology, The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Jikei University School of Medicine
Address 3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
Tel 03-3433-1111
Email h-rinken@jikei.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
2014 Year 04 Month 16 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
40 volunteers (20 males, 20 females) participated in this study. There was a tendency for the UES relaxation time to increase with swallowing volume. The dry swallow induced a significantly lower maximum UES pressure just after swallowing than did the 3-, 5-, and 10-ml swallows. The UES relaxation time was significantly prolonged with an increase in the bolus volume.

 It was found that reliable measurements can be obtained by measuring UES relaxaction time about 3 times and in other areas about 6 times.
Results date posted
2019 Year 08 Month 18 Day
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
2014 Year 01 Month 01 Day
Date of IRB
2013 Year 11 Month 11 Day
Anticipated trial start date
2014 Year 04 Month 16 Day
Last follow-up date
2019 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We examined the data for dysphagia patients were examined using this Manometry.Although there are different types of dysphagia,Dysphagia patients was confirmed to tend to UES pressure during UES dilatation is not sufficiently reduced.

Management information
Registered date
2014 Year 04 Month 16 Day
Last modified on
2019 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015967

Research Plan
Registered date File name
2017/01/19 研究実施計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/05/31 case 5(A portion correction).xlsx


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