UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058645 |
|---|---|
| Receipt number | R000066998 |
| Scientific Title | Feasibility and Safety of Observing the Cervical Esophagus Using a Portable Ultrasound Imaging Device in Young Healthy Participants: A Prospective Pilot Study |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/30 13:27:55 |
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Basic information
Public title
Observation of the Esophagus in Young Adult Using a Portable Ultrasound device
Acronym
Portable Ultrasound for Research of the Esophagus
Scientific Title
Feasibility and Safety of Observing the Cervical Esophagus Using a Portable Ultrasound Imaging Device in Young Healthy Participants: A Prospective Pilot Study
Scientific Title:Acronym
Portable Ultrasound for Research of the Esophagus
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility and safety of observing the cervical esophagus using a portable ultrasound imaging device in healthy young adults
Basic objectives2
Others
Basic objectives -Others
Feasibility/Safety
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of study participants in whom the cervical esophagus could be identified by ultrasound - using any method - while facing forward, regardless of probe position or angle.
Key secondary outcomes
1. The proportion of study participants in whom the cervical esophagus could be identified by ultrasound-using any method-while facing to the right, regardless of probe position or angle.
2. The proportion of participants in whom the cervical esophagus could be identified by ultrasound-using any method and regardless of scanning site or angle-according to age, sex, height, weight, BMI (Body Mass Index), neck circumference, neck length, and internal and external diameters of the cervical esophagus.
3. The proportion of participants in whom the cervical esophagus could be identified by ultrasound for each probe position and angle.
4. Association between the probe position and angle and the clarity (or quality) of cervical esophageal ultrasound images
5. Reasons for failure to identify the cervical esophagus by ultrasound.
6. Adverse events
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals aged 20 to 29 years
2. Individuals with no history of swallowing disorders or diseases of the neck, pharynx, or esophagus
3. Individuals with no significant physical or mental impairments
4. Individuals who have provided informed consent to participate in the study
Key exclusion criteria
1. Individuals who are pregnant
2. Individuals with implanted electronic medical devices such as pacemakers or glucose monitoring systems
3. Individuals with a history of surgical procedures above the chest
4. Individuals with a history of internal medical diseases from the head to the stomach
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Mikako |
| Middle name | |
| Last name | Notsu |
Organization
University of Shizuoka
Division name
School of Nursing
Zip code
422-8021
Address
2-2-1 Oshika, Suruga-ku, Shizuoka-shi, Shizuoka 422-8021, Japan
TEL
054-202-2946
notsu.m@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Mikako |
| Middle name | |
| Last name | Notsu |
Organization
University of Shizuoka
Division name
School of Nursing
Zip code
422-8021
Address
2-2-1 Oshika, Suruga-ku, Shizuoka-shi, Shizuoka 422-8021, Japan
TEL
054-202-2946
Homepage URL
notsu.m@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
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
University of Shizuoka Institutional Review Board
Address
52-1 Yada,Suruga-ku,Shizuoka 422-8526 Japan
Tel
054-264-5102
koho1@u-shizuoka-ken.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
| 2025 | Year | 08 | 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
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an exploratory study to investigate the feasibility of noninvasive observation of the cervical esophagus using a portable ultrasound device.
Management information
Registered date
| 2025 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066998
