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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019518
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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