UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049744 |
|---|---|
| Receipt number | R000056661 |
| Scientific Title | Establishment of a new esophageal motility evaluation method using a miniature ultrasound probe under a transnasal endoscope and its clinical application |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/06/14 18:14:54 |
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Basic information
Public title
New esophageal motility evaluation using a miniature ultrasound probe under nasal endoscopy
Acronym
Evaluation of esophageal motility using a miniature ultrasound probe under a nasal endoscope
Scientific Title
Establishment of a new esophageal motility evaluation method using a miniature ultrasound probe under a transnasal endoscope and its clinical application
Scientific Title:Acronym
Evaluation of esophageal motility using a miniature ultrasound probe under a nasal endoscope
Region
| Japan |
Condition
Condition
Patients with dysphagia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and establishment of a new method to evaluate esophageal wall distensibility as well as contraction of the esophageal muscule.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the endpoints obtained by esophageal manometry and those obtained by this method will be examined.
Key secondary outcomes
We will examine the relationship between the histological findings of the esophageal mucosa and the quantity of various proteins and cytokines.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 to 80 years complaining of dysphagia
Key exclusion criteria
Patients considered inappropriate by the physician in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Manabe |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama
TEL
+81-86-225-2111
n_manabe@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Manabe |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama
TEL
+81-86-225-2111
Homepage URL
n_manabe@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577, Matsushima, Kurashiki
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
| 2023 | Year | 02 | Month | 01 | 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
| 2022 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement of muscle layer thickness (analyzed separately for the striated medial and longitudinal muscles) and esophageal lumen area.
Management information
Registered date
| 2022 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056661
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
