UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048146 |
|---|---|
| Receipt number | R000054814 |
| Scientific Title | Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers. |
| Date of disclosure of the study information | 2022/06/23 |
| Last modified on | 2024/06/24 19:29:13 |
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Basic information
Public title
Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers.
Acronym
Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers.
Scientific Title
Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers.
Scientific Title:Acronym
Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers.
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the normative thresholds and normal findings of peristalsis of the esophageal body in healthy volunteers using high-resolution manometry (Distension-contraction plot method) and esophageal radiography (onigiri esophagography).
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationship between the Distension-contraction plot method and esophageal radiography (onigiri esophagography) findings.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establish the normative thresholds and normal findings for healthy volunteers in the Distension-contraction plot method.
Key secondary outcomes
Relationship between Distension-contraction plot method and esophageal radiography (onigiri esophagography) findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Esophageal radiography (onigiri esophagography)
Requires radiation exposure of about 20 mGy.
High-resolution manometry(Distension-contraction plot method)
The catheter must be inserted nasally, which is physically stressful during the examination.
It also requires water swallowing in the Trendelenburg position, which risks aspiration.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers who meet all of the following criteria are eligible.
(1) Subjects with no subjective symptoms that would raise suspicion of esophageal motility disorders
(2) Subjects who have been confirmed to have normal swallowing function
(3) Subjects who fully understand this research protocol and are able to give informed consent
(4) Subjects who are between 20 and 65 years old at the time of obtaining consent
Key exclusion criteria
Patients are excluded from the study if any one of the following criteria is applicable.
(1) Subjects who are taking drugs for improving gastrointestinal motility that may affect esophageal motility within 1 month of the examination
(2) Subjects who have undergone upper gastrointestinal surgery
(3) Pregnant women or subjects who may become pregnant
(4) Subjects who are allergic to Xylocaine or barium
(5) Subjects in poor general condition due to severe cardiopulmonary impairment, etc.
(6) Subjects who have difficulty understanding the examination protocol or listening to symptoms due to psychological disorders or cognitive impairment.
(7) Subjects who have been diagnosed with organic abnormalities such as malignant tumors before registration
(8) Subjects with other serious complications that are judged inappropriate by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Haruei |
| Middle name | |
| Last name | Ogino |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425286
ogino.haruei.600@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Tsuru |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425286
Homepage URL
tsuru.hirotaka.436@m.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyushu University
Department of Medicine and Bioregulatory Science
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Kyushu University
Department of Medicine and Bioregulatory Science
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
Kyushu University Institutional Review Board for Clinical Trials
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
0926425082
byskenkyu@jimu.kyushu-u.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
| 2022 | Year | 06 | Month | 23 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054814
