UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030819
Receipt number R000029774
Scientific Title Effective evaluation of the abdominal pressure device for stomach X-ray examination
Date of disclosure of the study information 2018/01/16
Last modified on 2018/06/13 13:05:28

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Basic information

Public title

Effective evaluation of the abdominal pressure device for stomach X-ray examination

Acronym

Effective evaluation of the abdominal pressure device for stomach X-ray examination

Scientific Title

Effective evaluation of the abdominal pressure device for stomach X-ray examination

Scientific Title:Acronym

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

1st name
Middle name
Last name Shuichi Wakimoto

Organization

Okayama University

Division name

Graduate School of Natural Science and Technology

Zip code


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

1st name
Middle name
Last name Koichi Shibuya

Organization

Okayama University

Division name

Graduate School of Health Sciences

Zip code


Address

2-5-1 Shikata-cho kita-ku Okayama

TEL

086-235-6876

Homepage URL


Email

kshibuya@md.okayama-u.ac.jp


Sponsor or person

Institute

Graduate School of Natural Science and Technology

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

48 cases were investigated. But the effectiveness of the Remote Control Pressured Pillow was not found.

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

Completed

Date of protocol fixation

2017 Year 01 Month 20 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029774


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name