UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017479 |
|---|---|
| Receipt number | R000020259 |
| Scientific Title | Quantitative assessment of pharyngeal and cervical esophageal pressure with High Resolution Manometry System |
| Date of disclosure of the study information | 2015/05/10 |
| Last modified on | 2015/05/09 17:25:11 |
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Basic information
Public title
Quantitative assessment of pharyngeal and cervical esophageal pressure with High Resolution Manometry System
Acronym
Measurement of pharyngeal and cervical esophageal pressure with High Resolution Manometry System
Scientific Title
Quantitative assessment of pharyngeal and cervical esophageal pressure with High Resolution Manometry System
Scientific Title:Acronym
Measurement of pharyngeal and cervical esophageal pressure with High Resolution Manometry System
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study each pressure of pharynx and cervical esophagus, quantitatively and objectively with High Resolution Manometry System. Clinically, to evaluate each part of swallowing function in a pharyngeal and esophageal cavity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Value of swallowing pressure from nasopharynx to cervical esophagus
Key secondary outcomes
Velocity of swallowing
Distal contractile integral in a cavity of oropharynx
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
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 that communication is possible
Patients have adequate function of vital organ
Patients provide written informed consent before initiation of study
Key exclusion criteria
Serious psychiatric disorder
Patients that will be inappropriate for entry into this study in the judgment of the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenkichiro Taira |
Organization
Tottori University Hospital
Division name
Depertment Otolaryngology:Head and Neck surgery
Zip code
Address
Nishimachi 36-1, Yonago, Tottori, Japan
TEL
0859-38-6627
kenkitiroutairaarea@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenkichiro Taira |
Organization
Tottori University Hospital
Division name
Depertment Otolaryngology:Head and Neck surgery
Zip code
Address
Nishimachi 36-1, Yonago, Tottori, Japan
TEL
0859-38-6627
Homepage URL
kenkitiroutairaarea@yahoo.co.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tottori University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 10 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2015 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020259
