UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effective evaluation of the abdominal pressure device for stomach X-ray examination
Title of the study (Brief title)	Effective evaluation of the abdominal pressure device for stomach X-ray examination
Region	Japan

Condition
Condition	malignant tumor
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effective evaluation of the abdominal pressure device for stomach X-ray examination
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	We compare the pillow to usually insert in the abdomen with the abdominal pressure device for stomach X-ray examination and inspect depiction range area in two folds of stomach anterior wall contrasting inspection. We perform it with a head low degree angle as uniformity for volunteers.
Key secondary outcomes	About an abdominal pressure device for stomach X-ray examination, We hear an abdominal pain by a questionnaire.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	We usually put pillows and, in two folds of stomach X-rays anterior wall contrasting photography, do it in head low degree, but We put an abdomen pressure device for developed stomach X-ray examination and compare the depiction range of both. In either case, it is said that the head low degree angle is constant. Time to need it is two minutes per 1 test person.
Interventions/Control_2	The intervention number of times to a subject is around two minutes only with one time of 1 test person
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	35 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	The test person who is the health condition that normal stomach X-ray examination is possible
Key exclusion criteria	We remove the following people. The test person whom others, a study person in charge, a study partaker judged to be inappropriate as a study subject more than dementia, stomach able person, 130 kg in weight.
Target sample size	50

Research contact person
Name of lead principal investigator	Shuichi Wakimoto
Organization	Okayama University
Division name	Graduate School of Natural Science and Technology
Address	3-1-1 Tsushima-naka kita-ku Okayama
TEL	086-251-8169
Email	wakimoto@act.sys.okayama-u.ac.jp

Public contact
Name of contact person	Koichi Shibuya
Organization	Okayama University
Division name	Graduate School of Health Sciences
Address	2-5-1 Shikata-cho kita-ku Okayama
TEL	086-235-6876
Homepage URL
Email	kshibuya@md.okayama-u.ac.jp

Sponsor
Institute	Graduate School of Natural Science and Technology
Institute
Department

Funding Source
Organization	Graduate School of Natural Science and Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 01 Month 20 Day
Last follow-up date	2018 Year 06 Month 13 Day
Date of closure to data entry	2018 Year 06 Month 13 Day
Date trial data considered complete	2018 Year 06 Month 13 Day
Date analysis concluded	2018 Year 06 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	48 cases were investigated. But the effectiveness of the Remote Control Pressured Pillow was not found.
Other related information

Management information
Registered date	2018 Year 01 Month 15 Day
Last modified on	2018 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029774