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
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
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
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
