UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028593 |
|---|---|
| Receipt number | R000032724 |
| Scientific Title | A new functional endoscopy for gastroesophageal reflux disease (GERD) for hiatal hernia cases: a prospective clinical trial on the usefulness of Endoscopic pressure study integrated system (EPSIS) |
| Date of disclosure of the study information | 2020/08/15 |
| Last modified on | 2017/08/09 00:23:48 |
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Basic information
Public title
A new functional endoscopy for gastroesophageal reflux disease (GERD) for hiatal hernia cases: a prospective clinical trial on the usefulness of Endoscopic pressure study integrated system (EPSIS)
Acronym
The usefulness of a new functional endoscopy (EPSIS) in the diagnosis of GERD for hiatus hernia
Scientific Title
A new functional endoscopy for gastroesophageal reflux disease (GERD) for hiatal hernia cases: a prospective clinical trial on the usefulness of Endoscopic pressure study integrated system (EPSIS)
Scientific Title:Acronym
The usefulness of a new functional endoscopy (EPSIS) in the diagnosis of GERD for hiatus hernia
Region
| Japan |
Condition
Condition
hiatal hernia
gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of EPSIS for GERD with hiatal hernia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra-gastric pressure max (IGP max)
Key secondary outcomes
The pattern of intra-gastric pressure
Scope holding time % (SHT %)
Scope holding sign (SHS)
Scope holding position (SHP)
Synchronicity and duration of intra-gastric pressure change and belching
Peristalsis
Cardiac opening (CO)
Sliding hernia (SH)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hiatus hernia.
Key exclusion criteria
Patients with pregnant
Patients who has severe complications(Heart disease, renal disease, liver disease and lung disease)
Patients with psychiatric disorders
Patients without informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiro Inoue |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL
03-6204-6000
haruinoue777@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Ominami |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive disease center
Zip code
Address
5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL
03-6204-6000
Homepage URL
komesoudoh@yahoo.co.jp
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Koto Toyosu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Based on the information obtained in the examination record of this study and the questionnaire, the evaluation items of the group without GERD symptoms (F scale: less than 8) and the group with GERD symptoms (F scale: 8 or more) were statistically .
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2017 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032724
