UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054930 |
|---|---|
| Receipt number | R000062104 |
| Scientific Title | Study for Endoscopic pressure study integrated system (EPSIS) |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/07/10 19:07:30 |
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Basic information
Public title
Study for Endoscopic pressure study integrated system (EPSIS)
Acronym
Study for EPSIS
Scientific Title
Study for Endoscopic pressure study integrated system (EPSIS)
Scientific Title:Acronym
Study for EPSIS
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining whether EPSIS is useful as a screening test for gastroesophageal reflux disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between EPSIS and 24-hour multichannel impedance pH monitoring test results
Key secondary outcomes
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
Performing EPSIS during upper gastrointestinal endoscopy in patients suspected of having GERD
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who suspect GERD and are scheduled to undergo upper gastrointestinal endoscopy and MII/pH monitoring at our hospital.
Key exclusion criteria
(1) Have an active infection.
(2) Have a heart disease with symptoms.
(3) History of uncontrolled mental disorder or central nervous system disorder.
(4) Pregnant patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kamei |
Organization
Tohouku University Hospital
Division name
Digestive Surgery
Zip code
9808574
Address
Seiryo-cho 1-1, Aoba-ku, Sendai City, Miyagi
TEL
0227177214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Ando |
Organization
Tohoku University Hospital
Division name
Digestive Surgery
Zip code
9808574
Address
Seiryo-cho 1-1, Aoba-ku, Sendai City, Miyagi
TEL
0227177214
Homepage URL
r-ando@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University 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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2024 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062104
