UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019518
Receipt number R000018875
Scientific Title Validation and clinical application of newly developed bioelectrical admittance method during the upper endoscopy - new underlying cause of GERD -
Date of disclosure of the study information 2015/10/27
Last modified on 2019/02/15 16:02:14

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Basic information

Public title

Validation and clinical application of newly developed bioelectrical admittance method during the upper endoscopy - new underlying cause of GERD -

Acronym

Bioelectrical admittance method during the upper endoscopy for patients with GERD

Scientific Title

Validation and clinical application of newly developed bioelectrical admittance method during the upper endoscopy - new underlying cause of GERD -

Scientific Title:Acronym

Bioelectrical admittance method during the upper endoscopy for patients with GERD

Region

Japan


Condition

Condition

GERD patients

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

validate our newly developed bioelectrical admittance method (numerically equal to the reciprocal of the impedance) of the gastrointestinal (GI) wall as a measure of both histological and functional GI mucosal integrity. This new method could differentiate patients with heartburn responding to PPI from those not responding to PPI

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the relationship between bioelectrical admittance value evaluated by this method and mucosal micro inflammation

Key secondary outcomes

bioelectrical admittance value evaluated by this method could be a marker to differentiate GERD patients responding to PPI from those without.


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

Treatment

Type of intervention

Medicine

Interventions/Control_1

carry out a newly developed bioelectrical admittance measurements during the upper GI endoscopy

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients were eligible for inclusion when they had symptoms of heartburn with the Frequency Scale for Symptoms of GERD (FSSG) score of 8 points or more. These subjects were either males or non-pregnant, non-breast feeding females aged between 20 and 70 years, and the blood examination and ultrasonography revealed no organic, systemic, or metabolic diseases for all patients.

Key exclusion criteria

No patients had undergone surgery of the digestive tract.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Manabe

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code


Address

577 Matsushima, Kurashiki, Okayama

TEL

086-462-1111

Email

n_manabe@hkg.odn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Manabe

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code


Address

577 Matsushima, Kurashiki, Okayama

TEL

086-462-1111

Homepage URL

https://www.kawasaki-m.ac.jp/med/kenkyu/06-02.html

Email

n_manabe@hkg.odn.ne.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Health, Labour and Welfare Ministry

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


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

川崎医科大学(岡山県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 27 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

Completed

Date of protocol fixation

2015 Year 01 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 27 Day

Last modified on

2019 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018875


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name