UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042661 |
|---|---|
| Receipt number | R000048677 |
| Scientific Title | A novel endoscopic diagnostic tool for gastroesophageal reflux disease: the endoscopic pressure study integrated system (EPSIS) : A multicenter prospective study |
| Date of disclosure of the study information | 2020/12/05 |
| Last modified on | 2024/12/11 00:00:24 |
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Basic information
Public title
A novel endoscopic diagnostic tool for gastroesophageal reflux disease: the endoscopic pressure study integrated system (EPSIS) : A multicenter prospective study
Acronym
A multicenter prospective study to evaluate the clinical usefulness of a novel diagnostic tool EPSIS for GERD
Scientific Title
A novel endoscopic diagnostic tool for gastroesophageal reflux disease: the endoscopic pressure study integrated system (EPSIS) : A multicenter prospective study
Scientific Title:Acronym
A multicenter prospective study to evaluate the clinical usefulness of a novel diagnostic tool EPSIS for GERD
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate EPSIS parameters and 24hr pH monitoring study, a standard diagnostic method for acid reflux.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Maximum intragastric pressure
- Waveform of intragastric pressure
- Gradient of waveform
- Parameters of acid reflux on 24hr pH monitoring study
(Acid Exposure Time, DeMeester Composite Score, Number of acid episodes, All reflux episodes, Symptom Index, Symptom Association Probability)
Key secondary outcomes
Synchronicity and duration of fluctuation of intragastric pressure with belching
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The measurement of intragastric pressure with EPSIS
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
1) Patients who have PPI or PCAB refractory GERD and undergoing workup for GERD (Upper endoscopy and 24hr pH monitoring)
2) Patients who have received complete information about the study and are willing to provide written consent
Key exclusion criteria
1) Patients who are pregnant
2) Patients with psychiatric disorders
3) Patients who have allergies to sedative drugs
4) Patients who have severe comorbidities (heart disease, renal disease, liver disease and lung disease)
5) Patients judged unsuitable to participate in the study by the physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Haruhiro |
| Middle name | |
| Last name | Inoue |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Diseases Center
Zip code
135-8477
Address
5-1-38 Toyosu, Koto-ku, Tokyo, Japan
TEL
03-6204-6000
haru.inoue@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Shimamura |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Diseases Center
Zip code
135-8477
Address
5-1-38 Toyosu, Koto-ku, Tokyo, Japan
TEL
03-6204-6000
Homepage URL
yutoshimamura1219@gmail.com
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Showa University Koto Toyosu Hospital
Address
5-1-38 Toyosu, Koto-ku, Tokyo, Japan
Tel
03-6204-6000
th_irb@ofc.showa-u.ac.jp
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
昭和大学江東豊洲病院 (東京都)
福岡大学医学部消化器外科（福岡県）
鳥取大学医学部附属病院（鳥取県）
大阪市立大学附属病院（大阪府）
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048677
