UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Validation and clinical application of newly developed bioelectrical admittance method during the upper endoscopy - new underlying cause of GERD -
Title of the study (Brief title)	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	Noriaki Manabe
Organization	Kawasaki Medical School
Division name	Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Address	577 Matsushima, Kurashiki, Okayama
TEL	086-462-1111
Email	n_manabe@hkg.odn.ne.jp

Public contact
Name of contact person	Noriaki Manabe
Organization	Kawasaki Medical School
Division name	Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
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
Institute	Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018875