UMIN-CTR Clinical Trial

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
Email	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
Email	tsuru.hirotaka.436@m.kyushu-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Kyushu University Department of Medicine and Bioregulatory Science
Institute
Department

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
Email	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	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	Open public 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	2022 Year 06 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054814

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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